# AVAVA, Inc.

- Location (FDA's records): Waltham, MA
- FDA decisions: 6 (2021–2025): 6 510(k) clearances
- Product codes: ONG (5), GEX (1)
- 510(k) review time since 2016: median 153 days, against 125 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 4 (4 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
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)
- Reliant Technologies, Inc.: 1 (https://510kreport.com/company/reliant-technologies)
- Quanta System Spa: 1 (https://510kreport.com/company/quanta-system)

## Its most-cited devices
- K202884: SR-1 Skin Treatment System (2021), cited by 1
- K223871: Miria Skin Treatment System (2023), cited by 1
- K221268: SR-1 Skin Treatment System (2022), cited by 1
- K250402: AVAVA™ Skin Treatment System (2025), cited by 1

## Recent decisions
- K252155: AVAVA™ Skin Treatment System (Oct 20, 2025)
- K250402: AVAVA™ Skin Treatment System (Apr 14, 2025)
- K223871: Miria Skin Treatment System (Jun 22, 2023)
- K221268: SR-1 Skin Treatment System (Nov 21, 2022)
- K213726: PL-1 Skin Treatment System (Jun 28, 2022)
- K202884: SR-1 Skin Treatment System (Apr 13, 2021)

Source page: https://510kreport.com/company/avava