# K024189: Nlite System, Model#: A00-1025/A00-1033

- Pathway: 510(k) (Traditional)
- Applicant: Icn Photonics, Ltd.
- Decided: Jun 20, 2003 after 183 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: 2 generations back to K000811 (2000). 2 ancestors in all.
328 later devices descend from it; 3 cite it directly.
0 of 331 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)
- K013461: Nlite System,Model A00-1025, Icn Photonics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K033461: Candela Vbeam Pulse Dye Laser System (2004), 316 descendants of its own
- K033331: Candela Cbeam Pulse Dye Laser System (2004), 230 descendants of its own
- K053047: Fraxel SR Laser System (2006), 205 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 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 Inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K024189
Methodology: https://510kreport.com/methodology