# Biolase, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 10 (2014–2022): 10 510(k) clearances
- Product codes: GEX (9), NVK (1)
- 510(k) review time since 2016: median 83 days, against 90 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 20 (4 its own); citations of its devices by later devices: 13 (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
- Biolase Technology, Inc.: 5 (https://510kreport.com/company/biolase-technology)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Fotona D.D.: 1 (https://510kreport.com/company/fotona-dd)
- Dental Photonics, Inc.: 1 (https://510kreport.com/company/dental-photonics)
- Quicklase Limited: 1 (https://510kreport.com/company/quicklase)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- Azena Medical, LLC: 1 (https://510kreport.com/company/azena-medical)
- Sciton, Inc: 1 (https://510kreport.com/company/sciton)

## Firms that cite its devices most
- Fotona D.O.O.: 3 (https://510kreport.com/company/fotona-doo)
- Medency S.R.L.: 2 (https://510kreport.com/company/medency)
- Enamel Pure: 1 (https://510kreport.com/company/enamel-pure)
- Viax Dental Lab: 1 (https://510kreport.com/company/viax-dental-lab)
- Azena Medical, LLC: 1 (https://510kreport.com/company/azena-medical)
- Guilin Kevin Peter Technology Co., Ltd.: 1 (https://510kreport.com/company/guilin-kevin-peter-technology)

## Its most-cited devices
- K192430: Epic 980 (2019), cited by 3
- K163128: Epic Pro (2017), cited by 3
- K161669: Waterlase Express (2016), cited by 2
- K190319: Waterlase Laser System Family (2019), cited by 2
- K193486: Epic 980 (2020), cited by 1
- K172771: Epic Pro 940 (2017), cited by 1

## Recent decisions
- K210183: Waterlase iPLus (Apr 21, 2022)
- K213428: EdgePro (Dec 22, 2021)
- K193486: Epic 980 (Mar 16, 2020)
- K192430: Epic 980 (Dec 4, 2019)
- K190319: Waterlase Laser System Family (Oct 10, 2019)
- K172771: Epic Pro 940 (Nov 29, 2017)
- K163128: Epic Pro (Jan 11, 2017)
- K161669: Waterlase Express (Jul 28, 2016)

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