# K003385: Twilite, Twilite White

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jan 25, 2001 after 86 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
No predicates in its family tree.
68 later devices descend from it; 3 cite it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021227: Softlase G2-Surgical Diode Laser System (2002), 56 descendants of its own
- K082938: Ezlase (2008), 50 descendants of its own
- K081214: Styla Microlaser and Stylaortho (2008), 50 descendants of its own
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own

Source page: https://510kreport.com/device/K003385
Methodology: https://510kreport.com/methodology