# K242996: EndyMed PRO MAX

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: Jun 10, 2025 after 257 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 355 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 357 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 5.
- K161199: EndyMed Contour Handpiece, Endymed Medical, Ltd. (2016) Summary page 5.
- K130501: Intensif, Endymed Medical, Ltd. (2014) Summary page 5.
- K101510: Fractional Skin Resurfacing (FSR) Applicator, Endymed Medical, Ltd. (2011) Summary page 5.

## Most influential descendants
- K251836: Dermatrix Duo (2026), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K242996
Methodology: https://510kreport.com/methodology