Lumenis FoLix
Hair restoration · Non-ablative fractional laser for hair restoration
Classification & configurations
Category group: Facial & wellness (hydradermabrasion, facials, recovery)
At a glance
- New price
- Not published
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK242349
- 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
K242349 (Lumenis Be, Ltd., 2024)
The FoLix System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 1, 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 | Lumenis |
|---|---|
| Company | Owner: Baring Private Equity Asia (BPEA, now part of EQT) (private equity owned, since 2019) · Distribution: direct |
| Parent company | Lumenis |
| Brand owner | Lumenis |
| Built by (OEM) | Lumenis Be Ltd. |
| Category | Hair restoration |
| Technology | Non-ablative fractional laser for hair restoration |
| FDA status | FDA Cleared |
| 510(k) citation | K242349 |
| 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
FoLix is a Lumenis non-ablative fractional laser system designed to improve scalp hair appearance. The system uses a cooled treatment tip.
Review the model-specific patient selection and treatment labeling when considering it for a practice.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K242349 (decision 9 Sep 2024). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K242349 (Lumenis Be, Ltd., 2024)
The FoLix System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Hair restoration — Non-ablative fractional laser for hair restoration
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Lumenis
Legal manufacturer: Lumenis Be Ltd. (Israel)
Applicant on the FDA record
Lumenis Be Ltd.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 Lumenis FoLix. 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.
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 purchase price, 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.
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 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://lumenis.com/aesthetics/products/folix/
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
FDA indication
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, "Lumenis FoLix — pricing, FDA status and cost to own", aestheticindex.co (accessed October 5, 2026).
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