# K061117: Nanolite Skin Care System

- Pathway: 510(k) (Abbreviated)
- Applicant: Nanolite Technology, Inc.
- Decided: Jun 20, 2006 after 60 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: 9 generations back to K943450 (1995). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 2.

## Indications for use
The Nanolite Skin Care System is indicated to treat pigmented lesions.

Source page: https://510kreport.com/device/K061117
Methodology: https://510kreport.com/methodology