# Endymed Medical, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 8 (2011–2025): 7 510(k) clearances and 1 De Novo grant
- Product codes: OUH (3), GEI (1), GEX (1), PAY (1), GYB (1), PBX (1)
- 510(k) review time since 2016: median 95 days, against 130 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 15 (5 its own); citations of its devices by later devices: 17 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endymion Medical, Ltd.: 4 (https://510kreport.com/company/endymion-medical)
- High Technology Products S.L.U: 1 (https://510kreport.com/company/high-technology-products-slu)
- Primaeva Medical, Inc.: 1 (https://510kreport.com/company/primaeva-medical)
- Electro-Cap Intl., Inc.: 1 (https://510kreport.com/company/electro-cap-intl)
- Venus Concept, Ltd.: 1 (https://510kreport.com/company/venus-concept)
- Viora, Ltd.: 1 (https://510kreport.com/company/viora)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)

## Firms that cite its devices most
- Alma Lasers, Inc.: 2 (https://510kreport.com/company/alma-lasers)
- Syneron Medical, Ltd.: 2 (https://510kreport.com/company/syneron-medical)
- Inmode MD, Ltd.: 2 (https://510kreport.com/company/inmode-md)
- El Global Trade, Ltd.: 1 (https://510kreport.com/company/el-global-trade)
- Ilooda Co,., Ltd.: 1 (https://510kreport.com/company/ilooda)
- Shenzhen Gsd Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-gsd-technology)
- Pollogen, Ltd.: 1 (https://510kreport.com/company/pollogen)
- Guangzhou Xinbo Electronic Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-xinbo-electronic)

## Its most-cited devices
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), cited by 5
- K130501: Intensif (2014), cited by 4
- DEN150005: Newa Skin Therapy System (2015), cited by 3
- K120513: Glow by Endymed (2012), cited by 2
- K242996: EndyMed PRO MAX (2025), cited by 1
- K161715: EndyGel (2017), cited by 1

## Recent decisions
- K242996: EndyMed PRO MAX (Jun 10, 2025)
- K222369: PURE Laser (Oct 7, 2022)
- K161715: EndyGel (Feb 7, 2017)
- K161199: EndyMed Contour Handpiece (Aug 1, 2016)
- DEN150005: Newa Skin Therapy System (Dec 18, 2015)
- K130501: Intensif (Mar 13, 2014)
- K120513: Glow by Endymed (May 8, 2012)
- K101510: Fractional Skin Resurfacing (FSR) Applicator (Feb 17, 2011)

Source page: https://510kreport.com/company/endymed-medical