Regulatory clarity
Is Cryoskin® FDA cleared?
No. Cryoskin® is a non-invasive cosmetic aesthetic spa device and is not represented as FDA-cleared, and DNA Distribution does not market it with medical claims. FDA 510(k) clearance on our range applies to two icoone® configurations only — Laser Beauty (K182453) and Laser-Med (K211272) — for four labeled indications.
- Cryoskin®: cosmetic aesthetic spa device
- icoone® laser models: 510(k) K182453 / K211272
- No medical claims for Cryoskin®
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The short answer
Cryoskin® is a spa device, and we sell it as one
Cryoskin® is a non-invasive cosmetic aesthetic spa device made in Lyon, France by Cryoskin® Paris. It is not FDA-cleared, and DNA Distribution does not represent it as FDA-cleared. We do not describe it as diagnosing, treating, curing or preventing any disease or condition, and it is not intended for obesity or weight loss.
What Cryoskin® is: a device that runs 20–28-minute body, skin and facial sessions as a relaxing warm-and-cool experience, with no suction cups and no downtime, after which skin looks firmer, smoother and more radiant. That is the whole claim, and it is deliberately the whole claim.
We would rather answer this question plainly on a public page than let a buyer discover the answer after a purchase. If a seller tells you Cryoskin® is FDA-cleared, that is a reason to slow down and verify who you are dealing with — not a reason to move faster.
Stated plainly
Cryoskin®
- Category: non-invasive cosmetic aesthetic spa device
- FDA clearance: not represented as FDA-cleared
- Medical claims: none made by DNA Distribution
- Operated by: trained estheticians and spa staff
- Manufacturer: Cryoskin® Paris, Lyon, France
- North American distributor: DNA Distribution (exclusive)
Definitions
What does “FDA-cleared” mean, and what does it not mean?
Cleared
A 510(k) clearance means the manufacturer demonstrated to the FDA that a specific device configuration is substantially equivalent to a legally marketed predicate device, for specific labeled indications. It is tied to that configuration and those indications.
Approved
A different and higher bar, used for premarket approval of certain device classes. "FDA approved" is not a synonym for "FDA cleared", and we never use it for anything in our range.
Registered / listed
Establishment registration and device listing are administrative steps. They are not clearance, not approval, and not an endorsement — and a marketer who blurs the three is telling you something about themselves.
Clearance also does not travel across a catalog. A brand does not become "FDA-cleared" because one model in the line is. That is precisely why the wording on our own site is model-specific.
Where clearance does apply
The two icoone® configurations that carry 510(k) clearance
DNA Distribution is an authorized U.S. distributor of icoone®, made in Bologna, Italy by I-Tech Industries. Two icoone® configurations — the laser-equipped ones — carry FDA 510(k) clearance, and only for the four indications stated in the clearance. We keep that wording exact everywhere it appears.
FDA 510(k) K182453 / K211272
Four labeled indications — laser-equipped configurations only
icoone® Laser Beauty and icoone® Laser-Med are cleared by the U.S. FDA for exactly these four indications, stated as labeled:
- 1Relief of minor muscle aches and pain
- 2Relief of muscle spasms
- 3Temporary improvement of local blood circulation
- 4Temporary reduction in the appearance of cellulite
Source: K182453 (icoone® Laser Beauty) · K211272 (icoone® Laser-Med). Non-laser configurations and icoone® Microfacial are not represented as FDA-cleared.
510(k) K182453
icoone® Laser Beauty
Roboderm® plus 915 nm laser and 650 nm LED, for face and body programs. $85,000.
See the model →510(k) K211272
icoone® Laser-Med
The flagship medical configuration, 40 programmes, laser and LED. $89,000.
See the model →Non-laser icoone® Beauty, icoone® Medical and icoone® Microfacial are professional cosmetic aesthetic configurations and are not represented as FDA-cleared. Full icoone® range →
Due diligence
What should you verify before you buy any aesthetic device?
- 01
Is the seller authorized?
Ask who the manufacturer is and whether the seller is listed by them. Cryoskin® Paris lists DNA Distribution on cryoskin-international.com/distributors, with a named contact and a phone number.
- 02
Is there a real warranty and real training?
A new Cryoskin® Revolution from DNA Distribution includes a 2-year device warranty and certification training. A private resale includes neither, whatever the listing says.
- 03
Does the language match the device?
Compare the seller’s marketing to the device’s actual regulatory scope. Overstated claims are a supplier risk that becomes your risk the moment it appears on your menu.
The fourth check is the least glamorous and the most useful: ask what happens in month seven. Who ships the part, who trains the new hire, who answers when the console behaves oddly. That answer separates an authorized purchase from a listing on a resale site — and it is the same answer that decides whether the room is still earning a year later.
New Cryoskin® Revolution vs. a used 3.0 / 4.0 → · What a Cryoskin® costs in 2026 →
Menu language
How to describe Cryoskin® sessions on your menu
Describe the experience
"A relaxing warm-and-cool Cryoskin® session, 20 to 28 minutes, for body, skin or face. No suction cups, no downtime — return straight to your day."
That is accurate, it is appealing, and it is the version your front desk can repeat without inventing anything.
Describe how skin looks
"Skin looks firmer, smoother and more radiant." Always "looks" — you are describing appearance, which is what a cosmetic aesthetic spa session is for.
Leave out medical claims, outcome percentages, measurements and timelines. They are not needed to sell the session, and they change the regulatory character of your marketing.
Our 90-Day Launch Program supplies menu copy, creative and funnel language written to this standard, so your first campaign does not have to be rewritten later. See the written terms → · Training and support →
Regulatory questions buyers ask
Is Cryoskin® FDA cleared?
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No. Cryoskin® is a non-invasive cosmetic aesthetic spa device and is not represented as FDA-cleared. DNA Distribution does not market it with medical claims and does not present it as diagnosing, treating, curing or preventing any disease or condition. It is sold and operated as a spa device for body, skin and facial sessions.
What does “FDA-cleared” actually mean?
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FDA clearance is a 510(k) decision: a manufacturer shows the FDA that a device is substantially equivalent to a legally marketed predicate device, for specific labeled indications. The clearance belongs to a particular device configuration and to those exact indications — not to a brand, a category, or everything a company sells.
Which devices does DNA Distribution sell that are FDA-cleared?
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Two icoone® configurations. icoone® Laser Beauty is cleared under 510(k) K182453 and icoone® Laser-Med under 510(k) K211272, each for four labeled indications: relief of minor muscle aches and pain; relief of muscle spasms; temporary improvement of local blood circulation; temporary reduction in the appearance of cellulite. Non-laser icoone® configurations and icoone® Microfacial are not represented as FDA-cleared.
Does a device need FDA clearance to be used in a spa?
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Not every device carries a 510(k) clearance — many professional cosmetic aesthetic spa devices are not, and are marketed as exactly that. What matters for you is honest labeling, an authorized supply chain and a menu description that matches the device’s actual scope. Your own state licensing and facility rules govern what your staff may offer.
What should I verify before buying any aesthetic device?
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Four things: that your seller is an authorized distributor, that the manufacturer lists them publicly, that a real warranty and certification training come with the unit, and that the regulatory language in the marketing matches the device’s actual scope. Cryoskin® Paris lists DNA Distribution at cryoskin-international.com/distributors.
How should my menu describe a Cryoskin® session?
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Describe the experience and how skin looks. A Cryoskin® session is a relaxing warm-and-cool experience of 20 to 28 minutes for body, skin and facial sessions, with no suction cups and no downtime, after which skin looks firmer, smoother and more radiant. Avoid medical claims, outcome percentages and result timelines in menu copy.
Ask us anything you would ask a lawyer to check
We would rather have this conversation before the purchase order than after. Tell us your setting — day spa, med spa, hotel, wellness studio, clinic — and a specialist will walk you through what each device in the range is, what it is not, and which one belongs on your menu.
Keep reading: Cryoskin® Revolution · Explore Cryoskin® for your practice · icoone® overview · icoone® vs Cryoskin® · General FAQ · Contact
Regulatory scope
Cryoskin® is intended solely for non-invasive cosmetic aesthetic use. It is not intended to diagnose, treat, cure, or prevent any disease or condition, and is not a treatment for obesity or weight loss. Individual results vary.
FDA-cleared wording on this site applies only to the laser-equipped icoone® configurations — icoone® Laser Beauty (510(k) K182453) and icoone® Laser-Med (510(k) K211272) — and only to their four labeled indications: relief of minor muscle aches and pain; relief of muscle spasms; temporary improvement of local blood circulation; temporary reduction in the appearance of cellulite. Non-laser icoone® configurations and icoone® Microfacial are not represented as FDA-cleared.
icoone® is a registered trademark of I-Tech Industries S.r.l. Outcome figures cited by the manufacturer come from i-Tech clinical evaluations; individual results vary. Any business, pricing or revenue examples are illustrative only.
Revenue and ROI figures shown on this site are illustrative estimates based on assumptions you select. They are not guarantees, projections, or promises of earnings. Actual results depend on your market, pricing, operations, and business practices.