# Premier Laser Systems, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 14 (1994–1999): 14 510(k) clearances
- Product codes: GEX (14)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 18 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Biolase Technology, Inc.: 4 (https://510kreport.com/company/biolase-technology)
- American Dental Technologies, Inc.: 3 (https://510kreport.com/company/american-dental-technologies)
- Photo Medex, Inc.: 2 (https://510kreport.com/company/photo-medex)
- Ics of North America, Inc.: 2 (https://510kreport.com/company/ics-of-north-america)
- Ceram Optec, Inc.: 2 (https://510kreport.com/company/ceram-optec)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)
- Carl Zeiss, Inc.: 1 (https://510kreport.com/company/carl-zeiss)
- CAO Group, Inc.: 1 (https://510kreport.com/company/cao-group)

## Its most-cited devices
- K954316: Aurora Surgical Diode Laser System W/Accessories (1995), cited by 7
- K981379: Aurora (1998), cited by 2
- K993285: Aurora SL (1999), cited by 2
- K974586: Aurora Diode Laser System (1998), cited by 2
- K961682: Argon Curing Laser (1996), cited by 1
- K932683: Centauri (1997), cited by 1

## Recent decisions
- K993285: Aurora SL (Nov 18, 1999)
- K992374: Aurora HL (Sep 22, 1999)
- K992620: Blulaze (Aug 20, 1999)
- K981379: Aurora (Nov 23, 1998)
- K983211: Centauri (Oct 9, 1998)
- K980559: Pegasus ND:Yag Laser System (Aug 24, 1998)
- K974586: Aurora Diode Laser System (Jul 15, 1998)
- K980561: Dermium (Mar 19, 1998)

Source page: https://510kreport.com/company/premier-laser-systems