# Venus Concept, Ltd.

- Location (FDA's records): Sunrise, FL
- FDA decisions: 11 (2010–2025): 11 510(k) clearances
- Names in FDA's records: Venus Concept , Ltd. (9); Venus Concept, Inc. (2)
- Product codes: GEI (6), ONF (3), GEX (1), PBX (1)
- 510(k) review time since 2016: median 88 days, against 87 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 21 (6 its own); citations of its devices by later devices: 20 (6 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
- Venus Concept USA, Inc.: 3 (https://510kreport.com/company/venus-concept-usa)
- Danish Dermatologic Development A/S: 2 (https://510kreport.com/company/danish-dermatologic-development-a-s)
- Mattioli Engineering Corp.: 2 (https://510kreport.com/company/mattioli-engineering)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Global Medical Technology S.L.: 1 (https://510kreport.com/company/global-medical-technology)
- Palomar Medical Technologies, Inc.: 1 (https://510kreport.com/company/palomar-medical-technologies)
- Invasix, Ltd.: 1 (https://510kreport.com/company/invasix)
- Viora, Ltd.: 1 (https://510kreport.com/company/viora)

## Firms that cite its devices most
- Venus Concept USA, Inc.: 7 (https://510kreport.com/company/venus-concept-usa)
- CAO Group, Inc.: 1 (https://510kreport.com/company/cao-group)
- Novoxel, Ltd.: 1 (https://510kreport.com/company/novoxel)
- Pollogen, Ltd.: 1 (https://510kreport.com/company/pollogen)
- Elettronica Valseriana Srl: 1 (https://510kreport.com/company/elettronica-valseriana)
- Endymed Medical, Ltd.: 1 (https://510kreport.com/company/endymed-medical)
- Ilooda Co,., Ltd.: 1 (https://510kreport.com/company/ilooda)
- Neauvia North America: 1 (https://510kreport.com/company/neauvia-north-america)

## Its most-cited devices
- K143554: Venus Legacy CX (2015), cited by 7
- K150161: Venus Viva SR Device (2015), cited by 4
- K100586: Venus Freeze System (2010), cited by 4
- K111670: Venus Freeze (MP)2 System (2012), cited by 2
- K153717: Venus Versa System (2016), cited by 1
- K111784: Venus Swan System (2011), cited by 1

## Recent decisions
- K252845: Venus Nova (FP-2001) (Nov 6, 2025)
- K232192: Venus Versa PRO System (Sep 11, 2023)
- K162765: Venus Velocity Diode Laser System (Jan 11, 2017)
- K153717: Venus Versa System (Mar 21, 2016)
- K152790: Venus Versa System (Jan 20, 2016)
- K143554: Venus Legacy CX (Aug 4, 2015)
- K150161: Venus Viva SR Device (May 12, 2015)
- K140629: Venus Swan (MP)2 (Jun 25, 2014)

Source page: https://510kreport.com/company/venus-concept