Cryotherapy and red light marketing claims

A wellness studio that sells cold chamber sessions, red or near infrared light sessions, or a membership that bundles both, sells an experience. The pressure in its marketing runs the other way: toward pain relief, weight loss, better skin, faster recovery and calmer moods. Those are health claims, and for whole body cryotherapy FDA has said in plain words that it has not cleared or approved any of these devices for the medical treatment of any specific condition. For light devices, FDA clearance exists for specific devices with specific indications, and a studio can say no more than that clearance or the device labeling says. This guide sets out what FDA has published, how to read a device’s status before you mention it, which claims to leave out, and why a signed waiver does not fix an ad.

Several neighboring topics have their own guides, so they are not repeated here. Clearance versus approval for medical devices in general is covered in medical device marketing claims, and laser caps and combs for hair are covered in hair restoration clinic marketing. Hyperbaric chambers, which a wellness studio may sell beside cold and light sessions, are covered in hyperbaric oxygen therapy marketing. Client stories and before and after photos are covered in testimonials and before and after photos, and weight claims in weight loss clinic marketing. Device claims for another common add-on service are covered in microneedling marketing. For sauna studios and heat sessions, see our guide to infrared sauna marketing claims. For ozone saunas and other ozone services, see ozone therapy marketing rules. Salt rooms and halotherapy are covered in our guide to salt therapy marketing claims. PEMF mats and clinic devices are covered in our guide to PEMF therapy marketing rules. Float tanks are covered in our guide to float therapy marketing claims.

This is general information, not legal or medical advice. Sources cited were checked on October 29, 2026: FDA consumer update, Whole Body Cryotherapy (WBC): A Cool Trend that Lacks Evidence, Poses Risks (content current as of July 5, 2016; FDA no longer serves it at its original address, so we link an archived copy from February 2024); FDA draft guidance, Photobiomodulation (PBM) Devices, Premarket Notification [510(k)] Submissions (issued January 12, 2023, still marked draft); FDA guidance, General Wellness: Policy for Low Risk Devices (January 6, 2026); FDA, Learn if a Medical Device Has Been Cleared by FDA for Marketing (content current as of December 29, 2017); 21 CFR 807.97; 15 U.S.C. 45 and 52; the FTC Health Products Compliance Guidance (December 2022); 16 CFR 255.2; and the Google Ads Healthcare and medicines and Misrepresentation policies. Questions about a health condition belong with the client’s own clinician. Have a health care attorney in your state review your services, your device paperwork and your marketing before you launch.

What FDA has said about whole body cryotherapy

FDA’s consumer update on whole body cryotherapy, or WBC, describes it as exposing the body to vapors that reach ultra low temperatures, ranging from minus 200 to minus 300 degrees Fahrenheit, for two to four minutes, either in a single person enclosure open at the top with the head outside, or in a chamber where several people sit or stand with the whole body, head included, exposed. It says FDA does not have evidence that WBC effectively treats diseases or conditions like Alzheimer’s, fibromyalgia, migraines, rheumatoid arthritis, multiple sclerosis, stress, anxiety or chronic pain, and that not a single WBC device has been cleared or approved by the agency in support of these claims.

The update lists the claims FDA found when it looked at how WBC is promoted: asthma, Alzheimer’s, anxiety, chronic pain, depression, fibromyalgia, insomnia, migraines, multiple sclerosis, osteoarthritis, rheumatoid arthritis and weight loss. It adds that sellers of machines and the facilities that run them may also claim that WBC can improve blood circulation, increase metabolism, improve recovery and soreness after workouts, and relieve joint and body pain. FDA says it informally reviewed the medical literature and found very little evidence about safety or effectiveness in treating the conditions for which WBC is being promoted.

On risk, the update names asphyxiation, especially when liquid nitrogen is used for cooling, because nitrogen vapor lowers the oxygen in a closed room and can cause hypoxia that could lead the user to lose consciousness. It also names frostbite, burns and eye injury from the extreme temperatures. It says FDA is concerned that people who choose WBC in place of treatments with established safety and effectiveness may see no improvement or a worsening of their condition, and it suggests discussing WBC with a physician before trying it. Its closing advice to consumers is direct: FDA has not cleared or approved any of these devices for medical treatment of any specific medical conditions.

A dating note matters. The update says content current as of July 5, 2016. As of our check on October 29, 2026, FDA no longer serves it at its original address, and the last copy we could retrieve from a public web archive is from February 2024. We did not find a newer FDA consumer page on WBC that replaces it. If you cite FDA on your site, cite this update with its date and say that it is an archived copy, and check again before each campaign.

What that means for cryotherapy copy

FDA’s list of promoted claims doubles as a list of claims to take off a cryotherapy studio’s site, menu boards, social posts and ads. Every condition on it is out. So are weight loss, metabolism, circulation, recovery and soreness, and joint or body pain, because FDA named them as claims sellers make and said it found very little evidence for them.

Three other lines cause trouble. FDA approved or FDA cleared cryotherapy is false for the claims FDA listed, by FDA’s own statement. Completely safe or no risk ignores the hazards FDA named. And language that positions a session as an alternative to medical care runs straight into FDA’s concern about people who choose WBC in place of treatment with established safety and effectiveness.

What a studio can describe is the session itself: what the chamber or enclosure is, how long a session lasts, what to wear, who is present, what happens before and after, what it costs and how to book. If the studio’s intake asks health questions or asks clients to check with their physician first, it can say so, as FDA suggests discussing WBC with a physician. It should not describe that intake as medical screening or medical clearance, because a front desk questionnaire is neither.

Red and near infrared light: clearance is device by device

FDA uses the term photobiomodulation, or PBM, for what studios sell as red light or low level light therapy. Its draft guidance on PBM device submissions, issued January 12, 2023 and still marked draft on FDA’s guidance page as of our check, defines it as the application of light at an irradiance that does not induce heating with the goal of altering biological activity. The same draft says the mechanism of action for different clinical indications is not fully understood, and that outcomes depend on wavelength, fluence, irradiance, pulsing parameters and beam spot size.

The draft lists the Class II product codes it covers. They include over the counter light based devices for acne and for wrinkle reduction, light based treatment for cold sores, a fat reducing low level laser, a hair laser comb, and a non heating light based instrument for adjunctive use in pain therapy. Each of those is a narrow, labeled indication. A device that reached the market for one of them was cleared for that indication, with the parameters in its submission, and not for red light therapy in general.

So before any page mentions FDA, do three things. First, get the 510(k) number and the indications for use statement for your exact model from the manufacturer, in writing. Second, look the device up yourself; FDA’s page on cleared devices points to its 510(k) releasable database for devices cleared through premarket notification. Third, compare: same model, same indication, used the way the labeling says, including whether the labeling is for over the counter or prescription use. If any of the three does not match, leave FDA out of your marketing for that device.

When the paperwork does match, describe the device in the words of its indication, and attach the claim to the device, not to the studio or to light therapy as a whole. 21 CFR 807.97 says that a substantial equivalence determination does not in any way denote official approval of the device, and that any representation creating an impression of official approval because of complying with the premarket notification rules is misleading and constitutes misbranding. FDA approved is therefore wrong for a cleared device, and FDA cleared stretched over a whole menu of services creates the impression 807.97 describes.

Wellness devices and what wellness does not cover

Not every light panel or bed in a studio went through 510(k). FDA’s General Wellness guidance, issued January 6, 2026, says CDRH does not intend to examine low risk general wellness products to decide whether they are devices or whether they meet device requirements. It defines general wellness claims to include relaxation or stress management, physical fitness, weight management and self esteem for products with a cosmetic function, and it lists claims that fall outside, such as a claim that a product will treat or diagnose obesity, or help treat an anxiety disorder.

Two parts of that guidance matter for marketing. It says a product’s inclusion under the wellness policy does not establish that it has been shown to be safe or effective for its intended use, so wellness status is not a claim of benefit. And it says FDA expects a wellness product’s labeling, including promotional materials and marketing communications, to be consistent with and not exceed the product’s stated intended use. A studio that adds pain, skin disease or weight loss treatment claims to equipment sold for wellness use is describing a use that the wellness policy does not cover.

The guidance also says a product is not low risk if it involves a technology that may pose a risk to users when specific regulatory controls are not applied, such as risks from lasers or radiation exposure. One of its own examples is a laser product that claims to rejuvenate the skin and improve confidence in appearance: those are general wellness claims, but the guidance says laser technology presents risks of skin and eye burns, so the product is not low risk. Whether a given light device is a wellness product or a device that needs clearance is a question for its manufacturer and FDA. Your job is to know which one you bought and market it accordingly.

Pain, weight, skin and recovery claims

Section 5 of the FTC Act, 15 U.S.C. 45, prohibits deceptive acts or practices, and section 12, 15 U.S.C. 52, makes it unlawful to disseminate a false advertisement for devices or services, among other things. The FTC Health Products Compliance Guidance says marketers should look at what reasonable consumers understand the ad as a whole to communicate, not narrowly at individual phrases, and that advertisers need a reasonable basis for their claims before an ad runs. It says the substantiation standard is a rigorous one, particularly when claims relate to health, and that as a general matter substantiation of health related benefits will need to be randomized, controlled human clinical testing to meet the competent and reliable scientific evidence standard.

Run each claim family through that test before it goes on a page.

Pain. Relieves pain, reduces inflammation, heals injuries and helps arthritis are treatment claims. FDA has said there is no WBC device cleared for them. For a light device, only an indication such as adjunctive use in pain therapy, cleared for that model, gives an FDA basis, and even then the claim stays in the words of the label and does not grow into healing or cure.

Weight. Burn calories, boost metabolism, lose inches and melt fat are body changes a client will measure. FDA named weight loss and metabolism among the unproven WBC claims. A fat reducing low level laser is a separate, specific cleared category; a red light bed is not that device unless its paperwork says so.

Skin. Collagen, anti aging, acne, scars, cellulite and rosacea claims vary from cosmetic to disease claims. Acne and wrinkle reduction appear as specific over the counter product codes in FDA’s draft, which means a device with that clearance can speak to that indication. A device without it cannot borrow it, and no device’s clearance supports a broad promise of younger skin.

Recovery and mood. Faster recovery, less soreness, better sleep, energy, less stress, less anxiety or depression relief. FDA listed recovery, soreness, anxiety, depression, insomnia and stress among the WBC claims it lacked evidence for. FDA’s wellness guidance treating relaxation or fitness as a wellness category is about whether FDA regulates the product; it does not lower the FTC’s evidence standard for an objective claim that the session will change how a body recovers or sleeps.

Studies help less than they seem to. The FTC guidance says consumers are likely to read words like promising, preliminary or pilot as positive attributes rather than as disclaimers about the state of the science, and that consumers may read an ad as a benefit claim even when it includes such language. Linking a single small study under a headline does not turn the headline into a substantiated claim.

A waiver is not a marketing shield

A studio may ask clients to sign a release or consent before a first session. Whatever that document does between the studio and the client, it does not change what the advertisement told the public. The FTC guidance says that although a clear and conspicuous disclosure might be effective to clarify an ambiguous claim, it cannot directly contradict a claim. One of its examples is an app sold for treating acne whose description also says it is for entertainment purposes only and not intended to treat any disease; the FTC calls that disclaimer directly contradictory and ineffective to negate the acne claim.

The same guidance says qualifying information must be clear and conspicuous, difficult to miss and easily understandable, that in online media disclosures should be unavoidable, and that disclosures made through hyperlinks are avoidable. A waiver signed after booking, a terms page, or a for entertainment purposes only line in a footer is none of those things. If an ad says the session relieves pain, the fix is to change the ad, not to add a sentence somewhere else.

The same logic applies when a studio site ends with a not intended to diagnose, treat, cure or prevent any disease line. If every other line on the page is a treatment claim, that footer contradicts the page rather than clarifying it.

Testimonials, reviews and before and after images

A client post that says the chamber fixed their back, or a before and after photo of skin after a light package, is a claim once the studio shares it. Under 16 CFR 255.2(b), an advertisement that conveys an endorser’s experience with a key attribute is likely to be read as showing what consumers will generally achieve, so unless the advertiser can substantiate that the experience is representative, the ad should clearly and conspicuously disclose the generally expected performance. For a claim the studio could not make itself, such as pain relief or weight loss, a client saying it does not help; the studio still needs substantiation for what the testimonial conveys. Our testimonials guide covers permission, editing and disclosure.

Google Ads and local listings

Google’s Misrepresentation policy does not allow inaccurate claims or claims that entice the user with an improbable result as the likely outcome a user can expect, even if that result is possible. Its Healthcare and medicines policy does not allow the promotion of speculative and/or experimental medical treatments. How Google applies either policy to a particular ad is Google’s decision, so write ads that do not depend on the answer: the session, the membership, the location, the hours and the booking link.

Choose a business profile category and description that match a wellness studio, not a medical clinic, and keep the health claims you removed from the site out of the description, the services list, the posts and the photos. Keyword lists matter too; bidding on condition terms such as fibromyalgia treatment or arthritis pain relief signals the same claim the ad text left out. Our healthcare ad policy basics and Google Ads for med spas guides cover account setup and approvals.

When a clinic offers cold or light sessions

A chiropractic, physical therapy or med spa practice that adds a cleared light device or a cold chamber is held to the same claims rules, with one more trap: the clinical setting makes every session look like treatment. Separate the two on the site. If a provider uses a cleared device as part of care, describe it within that service, in the words of its indication. If the clinic also sells walk in or membership sessions, put them on their own page, describe them as sessions, and do not carry treatment language or provider credentials across. Our guides to chiropractic marketing, physical therapy marketing and med spa marketing cover the rest of each specialty.

Illustration: a studio rewrites its menu

Illustration: a wellness studio’s old site sells a recovery membership with the headline FDA approved cryotherapy and red light, lists pain, inflammation, arthritis, anxiety and weight loss under benefits, links one small study, quotes a client who says the chamber cured their back pain, and ends with a footer that says not intended to treat any disease. The rebuilt site leads with the experience and the price, describes how a cold session works and how long it lasts, describes the light bed by what it is, and drops every benefit on the old list. It quotes FDA’s consumer update with its date as an archived copy and suggests clients ask their physician before a first session. The client quote and the study link are gone, and so is the footer line, because nothing on the page needs it.

Illustration: a physical therapy clinic has a light device whose indications for use statement reads adjunctive use in pain therapy. Its treatment page names the device type and that indication, inside the clinic’s description of care, without saying FDA approved or promising pain relief. The clinic’s separate recovery lounge page sells cold sessions by time and price and makes no health claims.

Checklist

Every disease or condition FDA listed for WBC removed from the site, menus, social posts, ads and the business profile.
No weight, metabolism, circulation, recovery, soreness, pain, mood or sleep outcome claims without randomized, controlled human testing behind them (15 U.S.C. 45, 52; FTC Health Products Compliance Guidance).
Never FDA approved. FDA cleared only for a light device whose 510(k) number and indications for use you have checked, for that model and that use.
Light devices described in the words of their indication, or, for wellness devices, without disease or treatment claims.
No safety promises; FDA’s named WBC risks reflected in your procedures and intake.
No language that positions a session as an alternative to medical care; a suggestion to check with a physician first.
FDA’s WBC update cited with its date and marked as an archived copy, if you cite it at all.
Waivers, terms and footer disclaimers not relied on to fix claims made in ads or on pages.
Testimonials and before and after images meet 16 CFR 255.2(b) and carry no claim you could not make yourself.
Ad text, keywords and business profile describe sessions, membership, location and hours, not conditions.
Clinical device use and walk in sessions on separate pages.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices and health businesses. For a cryotherapy or light studio, we can rebuild a website around the experience, membership and booking, check each device mention against its paperwork, cite FDA with dates and keep health claims out of pages, listings and ads. For clinics, we separate clinical device pages from session pages. Our tools are built with HIPAA in mind. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We do not sell lead lists and we do not pay for referrals. For the wider rules, see our healthcare marketing rules hub.

Is whole body cryotherapy FDA approved?

No. FDA’s consumer update, content current as of July 5, 2016, says FDA has not cleared or approved any whole body cryotherapy devices for medical treatment of any specific medical conditions, and that not a single device has been cleared or approved in support of claims such as chronic pain, anxiety, fibromyalgia or rheumatoid arthritis.

Can a cryotherapy studio advertise recovery or weight loss?

FDA named improved recovery and soreness after workouts, increased metabolism and weight loss among the claims made for whole body cryotherapy and said it found very little evidence for them. Under the FTC Act, health benefit claims need competent and reliable scientific evidence, generally randomized, controlled human trials.

Can a studio say its red light bed is FDA cleared?

Only if that exact model has a 510(k) clearance, the studio has checked its indications for use, and the claim is limited to that indication. Clearance is not approval, and 21 CFR 807.97 says implying official approval because of a premarket notification is misleading.

What does FDA’s general wellness policy mean for light devices?

FDA’s January 6, 2026 guidance says it does not intend to examine low risk products intended only for general wellness. It also says wellness status does not show a product is safe or effective, that marketing should not exceed the stated intended use, and that technologies with laser or radiation risks are not low risk.

Does a signed waiver protect a studio from claims in its ads?

No. The FTC’s guidance says a disclosure cannot directly contradict a claim and that disclosures must be clear and conspicuous. A release signed after booking or a footer disclaimer does not cure a pain relief or weight loss claim in an ad.

What can a cryotherapy or red light studio say in ads?

Describe the session, the membership, the price, the location, the hours and how to book. Leave out conditions, outcomes and FDA claims you have not verified, and keep condition keywords out of your campaigns.

Sources

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Cryotherapy and red light studio marketing: FDA status, health claims and ad copy