# K014130: Nlite System

- Pathway: 510(k) (Special)
- Applicant: Icn Photonics, Ltd.
- Decided: Jan 8, 2002 after 22 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.
667 later devices descend from it; 2 cite it directly.
0 of 668 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K023881: Profile 1064 Laser System (2003), 227 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 periocular wrinkles.

Source page: https://510kreport.com/device/K014130
Methodology: https://510kreport.com/methodology