# Biolase Technology, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 31 (1995–2013): 31 510(k) clearances
- Product codes: GEX (24), MXF (4), EFW (1), ILY (1), EFB (1)
- Predicates its devices cite: 75 (35 its own); citations of its devices by later devices: 72 (35 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Premier Laser Systems, Inc.: 4 (https://510kreport.com/company/premier-laser-systems)
- Kavo America: 4 (https://510kreport.com/company/kavo-america)
- Fotona D.D.: 3 (https://510kreport.com/company/fotona-dd)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Biolitec, Inc.: 2 (https://510kreport.com/company/biolitec)
- Hoya Photonics, Inc.: 2 (https://510kreport.com/company/hoya-photonics)
- American Dental Technologies, Inc.: 2 (https://510kreport.com/company/american-dental-technologies)
- Tycom Dental: 1 (https://510kreport.com/company/tycom-dental)

## Firms that cite its devices most
- Biolase, Inc.: 5 (https://510kreport.com/company/biolase)
- Convergent Dental, Inc.: 2 (https://510kreport.com/company/convergent-dental)
- Opusdent, Ltd.: 2 (https://510kreport.com/company/opusdent)
- Zap Lasers, LLC: 2 (https://510kreport.com/company/zap-lasers)
- Amd Lasers, LLC: 2 (https://510kreport.com/company/amd-lasers)
- Elexxion AG: 2 (https://510kreport.com/company/elexxion)
- CAO Group, Inc.: 2 (https://510kreport.com/company/cao-group)
- Cutera, Inc.: 2 (https://510kreport.com/company/cutera)

## Its most-cited devices
- K030539: Lasersmile (2003), cited by 7
- K082938: Ezlase (2008), cited by 5
- K061898: Ezlase (2007), cited by 5
- K121286: EPIC 10 (2012), cited by 4
- K011041: Waterlase, Millennium (2001), cited by 4
- K093852: Ezlase 3 Laser System (2010), cited by 4

## Recent decisions
- K122368: Waterlase Iplus All Tissue Laser (May 2, 2013)
- K130465: EPIC 10S (Apr 11, 2013)
- K121327: Diolase 10S (Feb 1, 2013)
- K121286: EPIC 10 (Sep 28, 2012)
- K101658: Waterlase MD Turbo Plus Model 7200XXX (Aug 11, 2010)
- K093852: Ezlase 3 Laser System (Mar 12, 2010)
- K091746: Waterlase MD, Model 7100102 (Dec 7, 2009)
- K083927: Waterlase MD (Oct 1, 2009)

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