# K082938: Ezlase

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Dec 22, 2008 after 81 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 169 ancestors in all.
50 later devices descend from it; 5 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003385: Twilite, Twilite White, Biolase Technology, Inc. (2001) Summary page 2.
- K993002: Ceralas D 980NM Diode Laser System, Model D15, Ceram Optec, Inc. (1999) Summary page 2.
- K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 2.
- K072106: 150W Ceralas D 980NM Diode Laser, Biolitec, Inc. (2007) Summary page 2.
- K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 2.

## Most influential descendants
- K121286: EPIC 10 (2012), 31 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K180044: SIROLaser Blue (2018), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own

## Indications for use
Light activation for bleaching materials for teeth whitening Laser-assisted whitening/bleaching of teeth

Source page: https://510kreport.com/device/K082938
Methodology: https://510kreport.com/methodology