EndyMed FSR handpiece
Fractional RF (non-needle) · Fractional skin resurfacing RF
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
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 ClearedK101510
- 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
K101510 (Endymed Medical, Ltd., 2011)
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
No new-equipment price range is published for this model. Ask the seller for a dated, itemized quote covering configuration, 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 | EndyMed |
|---|---|
| Company | Owner: OHMK Medical Technology Co. Ltd (China-linked); formerly majority-owned by Shanghai Haohai Biological Technology (subsidiary, since 2025) · Distribution: hybrid (direct + distributor) |
| Parent company | EndyMed |
| Brand owner | EndyMed |
| Built by (OEM) | EndyMed Medical Ltd. |
| Category | Fractional RF (non-needle) |
| Technology | Fractional skin resurfacing RF |
| FDA status | FDA Cleared |
| 510(k) citation | K101510 |
| New price range | Not published |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2013 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Resurfacing+tightening in one pass
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K101510 (Endymed Medical, Ltd., 2011)
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Fractional RF (non-needle) — Fractional skin resurfacing RF
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: EndyMed
Legal manufacturer: EndyMed Medical Ltd. (Israel)
Applicant on the FDA record
Endymed Medical, 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
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
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.
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History1 tracked change
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "EndyMed FSR handpiece — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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