# Venus Concept USA, Inc.

- Location (FDA's records): Weston, FL
- FDA decisions: 11 (2014–2022): 11 510(k) clearances
- Product codes: PBX (5), GEI (4), GEX (1), QAI (1)
- 510(k) review time since 2016: median 98 days, against 147 for FDA's reviews in the same codes and years (7 of 10 faster)
- Predicates its devices cite: 18 (7 its own); citations of its devices by later devices: 15 (7 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, Ltd.: 7 (https://510kreport.com/company/venus-concept)
- Cynosure, Inc.: 2 (https://510kreport.com/company/cynosure)
- Cytrellis Biosystems, Inc.: 1 (https://510kreport.com/company/cytrellis-biosystems)
- A-1 Engineering: 1 (https://510kreport.com/company/a-1-engineering)

## Firms that cite its devices most
- Venus Concept, Ltd.: 3 (https://510kreport.com/company/venus-concept)
- Eunsung Global Corp: 1 (https://510kreport.com/company/eunsung-global)
- Indiba S. A. U.: 1 (https://510kreport.com/company/indiba-s-a-u)
- Intelis Instruments, Ltd.: 1 (https://510kreport.com/company/intelis-instruments)
- B&M S.R.L. Marketing Nel Benessere: 1 (https://510kreport.com/company/b-m-marketing-nel-benessere)
- Lightfective, Ltd.: 1 (https://510kreport.com/company/lightfective)

## Its most-cited devices
- K142910: Legacy BX (2014), cited by 4
- K201164: Venus Viva MD Device (2020), cited by 3
- K191528: Venus Legacy Pro Device (2019), cited by 3
- K190743: Venus Bliss (2019), cited by 2
- K213308: Venus BlissMAX (2022), cited by 1
- K220592: Venus BlissMAX (2022), cited by 1

## Recent decisions
- K221011: AI.ME System (Dec 20, 2022)
- K220592: Venus BlissMAX (Apr 27, 2022)
- K213308: Venus BlissMAX (Jan 12, 2022)
- K211461: Family of Venus RF Systems - Venus Freedom (Oct 14, 2021)
- K201164: Venus Viva MD Device (Jun 26, 2020)
- K200786: Venus Epileve (Jun 9, 2020)
- K191065: Venus VivaTM (Apr 1, 2020)
- K191528: Venus Legacy Pro Device (Sep 6, 2019)

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