Category guide · updated Sep 2026
Cellulite devices for med spas: the one category where the clearance names it
Cellulite devices are the aesthetic equipment category built around the appearance of cellulite. icoone® Laser Beauty (510(k) K182453) and icoone® Laser-Med (510(k) K211272) are cleared for temporary reduction in the appearance of cellulite, among four labeled indications. Pricing runs $85,000 and $89,000 from DNA Distribution.
- Cleared indication on laser models
- 21,600 microstimulations/min
- Fewer than 100 U.S. devices
- From ≈ $1,730/mo, qualified
Alba answers instantly; a specialist follows up within minutes during business hours (9–7 ET). Prefer to talk now? Call (305) 563-3366.
The answer, first
Exactly what may be claimed, and on which models
Most pages in this category use the word loosely. This one does not, because the clearance language is both narrower and more useful than the marketing version.
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.
Read the fourth indication carefully: temporary reduction in the appearance of cellulite. Two qualifiers are doing real work there — temporary, and appearance. That is the claim, in the words the FDA cleared, and it belongs to two configurations only: icoone® Laser Beauty under 510(k) K182453 and icoone® Laser-Med under 510(k) K211272.
Non-laser icoone® Beauty, icoone® Medical and the icoone® Microfacial are professional cosmetic aesthetic devices. They are not represented as FDA-cleared anywhere on this site, and we do not attach the cellulite indication to them.
Why does this matter commercially? Because in a category where nearly every seller is vague, being able to hand a prospective client — or a state board, or your own marketing reviewer — a K-number and a one-line indication statement is a genuine competitive asset. It is the difference between a claim you can print and a claim you have to hedge.
icoone® Laser Beauty (K182453) → · icoone® Laser-Med (K211272) →
The technology
How icoone® produces the session behind that indication
Multi Micro Alveolar Stimulation. 86% of every Roboderm® microstimulator's surface is micro-holes, so a single pass delivers thousands of fractional stimulations rather than one broad action — up to 21,600 per minute at full speed.
Two hands at once. Twin motorised Robotwins handpieces work both sides of the body simultaneously. i-Tech states this two-hand robotic application is exclusive to icoone®, and on the floor it means full coverage in less chair time.
Non-thermal, with light on the laser models. The mechanical action is non-thermal mechanical stimulation. Laser Beauty and Laser-Med add a low-level 915 nm laser and a 650 nm LED — and those are the two configurations that carry the clearances.
The science it was built on. Roboderm® was patented in 2008 by Gianfranco Tudico, CEO of i-Tech Industries, following Prof. Jean-Claude Guimberteau's work on the microvacuolar structure of subcutaneous tissue. 15+ studies are published on icoone.com and a Scientific Committee of 40+ clinicians reviews the protocols.
icoone.com — the science pages · icoone.com — body cellulite programme
Key outcomes after the first session as reported by i-Tech Industries clinical evaluations; “up to” figures from published evaluations. Individual results vary.
Results archive
Before and after, as the manufacturer documents it
Selected pages from the icoone® Results Book published by i-Tech Industries. Each card records age, frequency, number of sessions and session time exactly as recorded.
The menu
What you actually put on the price list
The i-Tech programme library and its published protocol names give this service an identity on day one, instead of leaving you to invent one.
Console programmes
icoone® Beauty and Laser Beauty carry 24 beauty programmes; Medical and Laser-Med carry 40 (24 aesthetic plus 16 medical). The body library published by i-Tech includes cellulite appearance, reshaping, drainage, tightening, stretch marks, scars, relaxing massage and pregnancy programmes, with Grip 1/2/3 modes on the handpieces.
Eleven handpieces come with every body configuration: one Robosolo, two Robotwins, two Robomini, and one Robomicro with six attachments.
i-Tech protocol names your menu can license
- Perfect Shape 60′ — the body-led flagship protocol
- Detox Express 40′ — the short drainage-led session
- Body Glow 60′ — the skin-appearance body protocol
- Dynamic Skin Reactivation 50′
- Eating Enjoy 70′ — the long-format body course session
- Instant Well Being 20′ — the add-on that fills gaps in a schedule
These arrive named, timed and ready to price, which is a large part of why a first-to-market practice can launch a course-based body menu in weeks rather than months.
Which configuration
If the cleared indication matters to you, buy a laser model
This is the clearest buying rule on the whole site, so we will state it plainly.
Carries the indication
icoone® Laser Beauty
$85,000
≈ $1,860/mo (60 mo, $0 down, qualified; subject to approval)
Face and body, 24 programmes, 11 handpieces, 915 nm laser and 650 nm LED. 510(k) K182453. The most-purchased configuration for med spas.
Carries the indication
icoone® Laser-Med
$89,000
≈ $1,948/mo (60 mo, $0 down, qualified; subject to approval)
The flagship. 40 programmes (24 aesthetic + 16 medical), laser and LED, for clinic, physical-therapy, chiropractic and plastic-surgery settings. 510(k) K211272.
Laser-free
icoone® Beauty
$79,000
≈ $1,729/mo (60 mo, $0 down, qualified; subject to approval)
The full Roboderm® mechanical platform, face and body, 24 programmes, 11 handpieces — without the laser and LED handpieces, and therefore without the clearance.
| Model | Best for | Investment | Illustrative monthly* | Technology | Regulatory context | |
|---|---|---|---|---|---|---|
| icoone® Beauty | Aesthetic centers and spas building face + body programs without laser | $79,000 | ≈ $1,729/mo | Roboderm® Multi Micro Alveolar Stimulation · 24 programmes | Cosmetic aesthetic configuration | Get pricing & payment options |
| icoone® Laser Beauty | Aesthetic practices that want the laser + LED handpieces and the cleared indications | $85,000 | ≈ $1,860/mo | Roboderm® + 915 nm laser + 650 nm LED · 24 programmes | FDA 510(k) K182453 — four labeled indications | Get pricing & payment options |
| icoone® Medical | Clinics, physical-therapy, chiropractic and plastic-surgery practices (non-laser) | $87,000 | ≈ $1,904/mo | Roboderm® Multi Micro Alveolar Stimulation · 40 programmes (24 aesthetic + 16 medical) | Cosmetic aesthetic configuration | Get pricing & payment options |
| icoone® Laser-Med | The flagship: medical practices that want laser + LED and the cleared indications | $89,000 | ≈ $1,948/mo | Roboderm® + 915 nm laser + 650 nm LED · 40 programmes (24 aesthetic + 16 medical) | FDA 510(k) K211272 — four labeled indications | Get pricing & payment options |
Pricing as of Sep 2026. *Financing is subject to applicant qualifications and independent provider approval. Illustrative monthly figures assume a 60-month term with $0 down for qualified buyers. Every full-price device includes training, shipping, installation, warranty and the 90-Day Launch Program (written terms apply).
The full icoone® cost breakdown → · How the financing works →
Market position
A cleared indication almost nobody near you can print
Cellulite is one of the most searched terms in aesthetics and one of the most loosely marketed. That combination is an opportunity for a practice willing to be precise.
You can advertise a specific, cleared indication with a K-number behind it, on a platform installed in 7,000+ centers in 40+ countries — while there are fewer than 100 devices in the entire United States. In most metros nobody else can say the same sentence.
The manufacturer's reference wall does the rest: Four Seasons, Ritz-Carlton, Mandarin Oriental, Aman, Chanel, Six Senses, Dior Spa at The Lana in Dubai. Those are icoone® installations worldwide published by i-Tech, not DNA Distribution clients — but they are the association your marketing gets to stand beside.
icoone® in residence at
Installed worldwide · 7,000+ centers in 40+ countries (i-Tech Industries)
- Four Seasons
- The Ritz-Carlton
- Dior Spa · The Lana, Dubai
- Mandarin Oriental
- Aman
- Chanel
- Six Senses
- The Peninsula
- St. Regis
- Belmond
- Waldorf Astoria
- Equinox Hotel New York
- SHA Wellness Clinic
- Clinique La Prairie
- Dorchester Collection
- Molitor Paris
- Bürgenstock
- MGM
- NoMad London
- Cullinan Belek
- L’Ermitage
- Verba Mayr
- Clinique del Mar
- Selman Marrakech
- Rosa Springs
- Quinta da Pacheca
- Mriya Resort & Spa
Reference list published by i-Tech Industries, the manufacturer of icoone®. These are icoone® installations worldwide, not DNA Distribution clients.
Alongside it
Where Cryoskin® fits on the same menu
DNA Distribution also carries Cryoskin® Revolution, and it belongs on this page for one reason only: many practices building a body-focused menu run both, at different price points.
Cryoskin® Revolution is a cryo-thermal aesthetic spa device made in Lyon, France by Cryoskin® Paris. It runs body, skin and facial sessions in 20–28 minutes with a handheld wand — a relaxing warm-and-cool experience, no suction cups, no downtime, and skin that looks firmer, smoother and more radiant. These are body sessions clients rebook, which is what fills a weekday afternoon.
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. It is not represented as FDA-cleared, and the cellulite indication described above belongs to the icoone® laser configurations only.
Entry pricing is $39,990 (≈ $875/mo, 60 mo, $0 down, qualified; subject to approval). Many partners run both lines — ask about combination pricing when you book.
Cryoskin® Revolution → · icoone® vs Cryoskin® → · Body contouring devices → · Lymphatic drainage devices →
Economics
What a course-based body menu looks like on a P&L
Body work on icoone® is usually sold as a course, not a single session, which is what makes the economics work. Set the planner to the session price and frequency you would actually book. It deducts the illustrative financed payment and consumables — remember to put the body suit into the consumables slider — and nothing else. It is an illustration, not a forecast or a financing quote.
Illustrative session-economics planner
Illustration, not a forecast or financing quoteAssumption: sessions/day × price × operating days, minus an illustrative 60-month, $0-down payment (factor 0.02188 per dollar financed, subject to approval) and consumables. Does not deduct staff, rent, marketing or taxes, and does not assume utilization. Not a guarantee, projection, or promise of earnings; actual results depend on your market, pricing and operations.
The full session-economics guide → · The 90-Day Launch Program →
Launch
A first-to-market service still has to be explained
- 01
Certification training
Included with every full-price device. Handpieces, grip modes, the programme library and the body protocol menu, taught until your therapists are certified.
- 02
90 days of funded demand
$10,000 of program value: managed marketing and up to $2,500 of ad spend across 90 days, with our landing page, funnel, CRM and same-day lead response. Runs to 30 booked paying clients or day 90, whichever comes first.
- 03
A named menu on day one
The i-Tech protocol names arrive timed and ready to price, so the service launches with an identity rather than as “the new machine in room two”.
90-Day Launch Program
Pay full price — we fund your first 90 days of ads and marketing.
$10,000 program value, on us (managed marketing + up to $2,500 ad spend).
- Paid ads built and managed by our team, up to $2,500 ad spend included
- Landing page, funnel and CRM configured for your practice
- Same-day lead response with Alba and our appointment setters
- Runs until 30 booked paying clients or day 90, whichever comes first
*Full-price device purchases only; not combinable with promotions, discounts, or demo units. Includes fully managed marketing and an ad budget of up to $2,500 across 90 days. Program runs from marketing go-live until 30 booked paying clients or 90 days, whichever comes first. Requires Launch Playbook participation (our pricing, creatives, funnel, same-day lead response).
Practice fit
Find the right configuration in six questions
Answer six short questions so Alba and a specialist can prepare a relevant conversation. Ready buyers get a priority slot.
- · Public pricing on every model, no gate
- · Financing terms explained on the call, subject to approval
- · Alba replies instantly; a specialist follows within minutes (9–7 ET)
Questions buyers ask
Which cellulite device is FDA-cleared?
+
In our range, the two laser-equipped icoone® configurations. icoone® Laser Beauty under 510(k) K182453 and icoone® Laser-Med under 510(k) K211272 are each cleared for four labeled indications, one of which is temporary reduction in the appearance of cellulite. Non-laser icoone® Beauty, icoone® Medical and the icoone® Microfacial are not represented as FDA-cleared.
What exactly does the clearance say?
+
The four labeled indications, verbatim, are: relief of minor muscle aches and pain; relief of muscle spasms; temporary improvement of local blood circulation; temporary reduction in the appearance of cellulite. Note the wording — temporary, and appearance. That is what may be claimed, and it applies only to icoone® Laser Beauty and icoone® Laser-Med.
How much does an icoone® cellulite device cost?
+
icoone® Laser Beauty is $85,000 (≈ $1,860/mo) and icoone® Laser-Med is $89,000 (≈ $1,948/mo) — the two configurations carrying the cleared indication. The laser-free icoone® Beauty is $79,000 (≈ $1,730/mo). All monthly figures assume a 60-month equipment term loan at $0 down for qualified buyers, subject to applicant and provider approval.
How does icoone® work?
+
Patented Roboderm® microstimulators, whose surface is 86% micro-holes, deliver up to 21,600 fractional microstimulations per minute — Multi Micro Alveolar Stimulation — applied with two motorised hands at once over a client body suit. It is non-thermal mechanical stimulation; the laser configurations add a low-level 915 nm laser and a 650 nm LED.
What does a session look like?
+
Body sessions are worked over a client body suit with motorised handpieces, most often as a course rather than a one-off. i-Tech publishes a body cellulite programme in the console library, plus named spa protocols your menu can license, such as Perfect Shape 60′, Detox Express 40′ and Body Glow 60′.
Are there consumables?
+
Body sessions use a client body suit, which is a real per-client cost to budget. There are no tips, cartridges or applicators to replace on any icoone® configuration, and no per-session licence fees. That makes cost of ownership easy to model over a 60-month term.
How many icoone® devices are in the United States?
+
Fewer than 100, against 7,000+ centers in 40+ countries worldwide and 6M+ sessions a year per i-Tech Industries. In most U.S. metros the first icoone® practice has not opened, which means the first buyer in a market generally sets the price and names the protocol.
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.