DEKA Onda Coolwaves
RF body contouring · 2.45GHz microwave fat disruption
At a glance
- New price
- $100k–$150kSource not documented
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK260647
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 1 FDA record
K260647 (El.En S.P.A., 2026)
The SPECCHIO RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The SPECCHIO massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$150k. Reference figures, not current offers.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | DEKA (Cartessa) |
|---|---|
| Company | Owner: El.En. Group S.p.A. (Euronext Milan: ELN), ~85% (subsidiary, since 2012) · Distribution: via distributor — Cartessa Aesthetics (exclusive US distributor) |
| Parent company | Cartessa Aesthetics |
| Brand owner | DEKA |
| Built by (OEM) | DEKA M.E.L.A. S.r.l. |
| Category | Body Contouring |
| Technology | 2.45GHz microwave fat disruption |
| FDA status | FDA Cleared |
| 510(k) citation | K260647 |
| New price range | $100k–$150k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2021 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Microwave-based fat, cellulite, laxity
How it worksTechnology and manufacturing
How the technology works
Coolwaves are 2.45GHz microwaves — fundamentally different from RF (MHz) or laser — delivered through cooled handpieces.
At that frequency energy deposits preferentially in subcutaneous fat and connective septa rather than the water-rich dermis, disrupting adipocyte membranes and remodeling the fibrous septa behind cellulite dimpling.
Integrated contact cooling protects the epidermis, so deep heating happens with less surface pain than monopolar RF. Effect: cellulite smoothing, localized pocket reduction, secondary tightening over 3-4 monthly sessions.
Patented technology
Coolwaves is DEKA's patented 2.45GHz microwave delivery with depth-selective handpieces — Deep (fat), Shallow (laxity/cellulite), and the new Pocket applicator on Onda PRO for small fibrotic areas.
Origin
DEKA M.E.L.A. (El.En.
Group), Calenzano, Florence, Italy; Cartessa is exclusive US/Canada distributor.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K260647 (decision 2 Apr 2026); the cleared trade name is SPECCHIO. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K260647 (El.En S.P.A., 2026)
The SPECCHIO RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The SPECCHIO massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF body contouring — 2.45GHz microwave fat disruption
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Cartessa Aesthetics
Legal manufacturer: DEKA M.E.L.A. S.r.l. (Italy)
Applicant on the FDA record
El.En. S.p.A.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
No per-treatment disposables; the cost reality is handpiece cooling maintenance and eventual applicator replacement — verify handpiece lifetime pricing with Cartessa; that's where money hides on cooled-tip systems.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published DEKA Onda Coolwaves data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the midpoint of the published new-price range
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Pregnancy, implanted electronic devices, metal implants in field, active malignancy, hernia at the site, impaired sensation or circulation.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
No confirmed chain deployments recorded yet.
Owner & operator reviews
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "DEKA Onda Coolwaves — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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