General & Plastic Surgery › SurgicalSkin Resurfacing Rf Applicator

EndyMed PRO MAX, FSR MAX Handpiece

Name: EndyMed PRO MAX, FSR MAX Handpiece
Brand: EndyMed PRO MAX, FSR MAX Handpiece

The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic procedures. The FSR Max Handpiece is intended for…

Registry build 21.09.26

The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic procedures. The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin.

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OUH
Manufacturer	City	Province	Registered as	Device types
Beijing Syntech Laser Co., Ltd.	Beijing	Beijing	Contract manufacturer	5
Guangdong Fuqiang Beauty Equipment Co., Limited	Qingyuan	Guangdong	Manufacturer	13

Record

Regulatory record for EndyMed PRO MAX, FSR MAX Handpiece
Listed by	Endymed Medical Ltd, Israel
FDA product code	OUH
Device type	Skin Resurfacing Rf Applicator
Device class	Class 2
Regulation	21 CFR 878.4400
Establishment	Manufacturer
Record published	2024-05-16
Record revised	2025-11-18 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for EndyMed PRO MAX, FSR MAX Handpiece
Catalogue number	Size	Status
FSR MAX Handpiece		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
INTRAgen Tip	Jeisys Medical Inc.	2
INTRAgen	Jeisys Medical Inc.	1
Max-M25C	Classys Inc	1
Virtue RF Microneedle Cartridge	ShenB Co Ltd	1
Quadessy Set Package	Classys Inc	1
Virtue RF	ShenB Co Ltd	1
Max-M25	Classys Inc	1
EndyMed Intensif 10 pack tips package	Endymed Medical Ltd	1
Max-25C	Classys Inc	1
Max-25	Classys Inc	1
Vivace Electrosurgical System	ShenB Co Ltd	1
Fraxis Duo Needle H/P	Ilooda Co,., Ltd.	1

Showing 12 of 24. All products under Skin Resurfacing Rf Applicator

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130501	2014-03-13
K120513	2012-05-08
K101510	2011-02-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.