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EndyMed PRO MAX

Endymed Medical, Ltd.

Country / Region:Israel (IL)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

Israel (IL)

Product code

GEI
21 CFR 878.4400

Predicate devices

4

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K242996
Device name
EndyMed PRO MAX
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

Predicate devices

4

K242996 references 4 predicate/reference devices

Cited as predicate

1

1 submission cite K242996 as a predicate