Manufacturer
Endymed Medical, Ltd.EndyMed PRO MAX
Country / Region:Israel (IL)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Device details
FDA 510(k) registration fields
- K number
- K242996
- Device name
- EndyMed PRO MAX
- Company
- Endymed Medical, Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-09-26
- Decision date
- 2025-06-10
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- Pain ManagementOther
- Primary application
- Pain Management
- Classification source
- AI classified
Indications for Use
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
Intended Use
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.
Device Description
ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emitted onto patient skin. The device consists of a console and seven handpieces that emit either ablative or non-ablative radiofrequency.
Summary parsed at:2026-06-20 17:45:36 UTC
