# K000811: Nlite System, SLS Model Number A00-1025

- Pathway: 510(k) (Traditional)
- Applicant: Sls Biophile, Ltd.
- Decided: Aug 25, 2000 after 165 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.
771 later devices descend from it; 7 cite it directly.
0 of 772 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
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) (2002), 740 descendants of its own
- K013461: Nlite System,Model A00-1025 (2002), 711 descendants of its own
- K013043: Candela Clearbeam Pulsed Dye Laser (2001), 703 descendants of its own
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own

Source page: https://510kreport.com/device/K000811
Methodology: https://510kreport.com/methodology