DEKA HELIX
CO2 Fractional/Ablative · Combined CO2 and non-ablative resurfacing platform
Technology: CO2 Fractional Laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- Not published
- FDA status
Record scope: 510(k): K222221 (decision 4 Jan 2023). Checked 4 Sep 2026.
- Supplies & recurring costs
- Supply details not yet documented.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeK222221
- 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.
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Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 1 FDA record
K222221 (El.En Electronic Engineering Spa, 2023)
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 6, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | DEKA |
|---|---|
| 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 | El.En. Group |
| Brand owner | DEKA |
| Built by (OEM) | DEKA M.E.L.A. S.r.l. |
| Category | CO2 Fractional/Ablative |
| Technology | Combined CO2 and non-ablative resurfacing platform |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K222221 |
| New price range | Not published |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | Not published |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
HELIX is a DEKA resurfacing platform combining a 10,600 nm CO2 laser with a 1570 nm non-ablative laser. It offers separate and combined treatment approaches; settings and configuration determine treatment intensity.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K222221 (decision 4 Jan 2023). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K222221 (El.En Electronic Engineering Spa, 2023)
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
CO2 fractional — Combined CO2 and non-ablative resurfacing platform
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: El.En. Group
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
Treatment and running-cost details aren’t documented yet.
Ask the supplier for the session schedule, supplies per treatment and annual service costs.
Use your own figures in the calculatorPayback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for DEKA HELIX. Published figures appear where available; review them before using the estimate.
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.
New price not published — enter the number on your quote.
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.
Required — include staff time and your own time. Enter 0 only to explicitly exclude labor from this estimate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter purchase price, price you charge per treatment, consumable cost per treatment, labor 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.
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.
History7 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 6, 2026
DEKA/BTL model documentation and corrections
{"product_url": null} → {"product_url": "https://www.cartessaaesthetics.com/products/helix"}
Source review on October 6, 2026 of the changed fields only. Prices, lifecycle status and other unchanged fields are not reverified by this update. International brochures do not establish US indications or current service availability.
Source: https://www.cartessaaesthetics.com/products/helix
October 1, 2026
Sourced profile overview
Added a neutral overview from the linked manufacturer or official US distributor source. This is field-specific sourcing, not verification of every other profile field.
Source: https://dekalaser.com/products/helix/
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
Cite this data: The Aesthetic Index, "DEKA HELIX — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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