EndyMed PRO
RF body contouring · 3DEEP multisource phase-controlled RF
At a glance
- New price
- $50k–$80kSource not documented
- Used asking price
- $8k–$20kSource 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
- 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. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 4 FDA records
K242996 (Endymed Medical, Ltd., 2025)
The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece. The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin. The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis. The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
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.
K130501 (Endymed Medical, Ltd., 2014)
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K161199 (Endymed Medical, Ltd., 2016)
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 8, 2026 · How we verify
Axis runs $0–$80k. Reference figures, not current offers. Used asking prices are not completed-sale values.
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 | 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 | Body Contouring |
| Technology | 3DEEP multisource phase-controlled RF |
| FDA status | FDA Cleared |
| 510(k) citation | K242996, K101510, K130501, K161199 |
| New price range | $50k–$80k |
| Used asking range | $8k–$20k |
| Consumables | Not published |
| Launch year | 2010 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
BodyShaper handpiece for contouring
How it worksTechnology and manufacturing
How the technology works
The Intensif adds 25 non-insulated gold-plated tapered needles to 5mm depth, delivering RF along the full needle shaft for a larger coagulation column per insertion; its shock-free pneumatic insertion reduces dragging and bleeding versus stampers.
The same console runs non-invasive tightening (FSR/iFine) and body handpieces — one box covers fractional resurfacing, laxity, and contouring.
Patented technology
Patented 3DEEP multisource phase-controlled RF — six generators with real-time impedance feedback versus the single-generator bipolar design of most rivals; the Intensif's non-insulated tapered gold needle geometry is proprietary too.
Origin
Caesarea, Israel (EndyMed Medical).
FDA & regulatory detailClearance timeline, authorization route and citation notes
Platform clearance: K242996 (EndyMed PRO MAX, decision 10 Jun 2025) is the current platform record; the PRO's handpieces are cleared under K101510 (FSR applicator, 17 Feb 2011), K130501 (Intensif, 13 Mar 2014) and K161199 (Contour, 1 Aug 2016). No 510(k) naming 'EndyMed PRO' alone was located. Checked 8 Sep 2026.
FDA-cleared indications (verbatim)
K242996 (Endymed Medical, Ltd., 2025)
The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece. The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin. The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis. The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
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.
K130501 (Endymed Medical, Ltd., 2014)
The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K161199 (Endymed Medical, Ltd., 2016)
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF body contouring — 3DEEP multisource phase-controlled RF
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
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
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
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 EndyMed PRO 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
Implanted pacemakers/defibrillators or metal in the area, pregnancy, active infection or inflammatory conditions in the zone, uncontrolled diabetes affecting healing. Safe across Fitzpatrick types with respected parameters.
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
Write a reviewNo owner or operator reviews yet. Be the first →
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.
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
K242996; K101510; K130501; K161199
Source: Record correction
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242996
Source: Record correction
September 4, 2026
science
Unsourced evaluative sentence removed under the opinion-layer gate.
Source: Catalog update — Wave D opinion-layer gate, 2026-09-04
August 5, 2026
FDA indication
Source: Catalog update
August 5, 2026
Warranty & service
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, "EndyMed PRO — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
Get the full State of Aesthetic Devices 2026 report
A catalog of US-marketed aesthetic and wellness devices — preview it free.
Device and company names are trademarks of their respective owners. The Aesthetic Index is not affiliated with or endorsed by any manufacturer, distributor or lender named here, except as disclosed. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.