# K013461: Nlite System,Model A00-1025

- Pathway: 510(k) (Traditional)
- Applicant: Icn Photonics, Ltd.
- Decided: Jan 17, 2002 after 91 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: 1 generation back to K000811 (2000). 1 ancestor in all.
711 later devices descend from it; 5 cite it directly.
0 of 713 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000) Summary page 1.

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K024189: Nlite System, Model#: A00-1025/A00-1033 (2003), 328 descendants of its own
- K021180: Candela Vbeam Pulsed Dye Laser System (2002), 318 descendants of its own

## Indications for use
The NLite System is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of wrinkles.

Source page: https://510kreport.com/device/K013461
Methodology: https://510kreport.com/methodology