# K020729: Nlite System,Model A00-1051

- Pathway: 510(k) (Traditional)
- Applicant: Icn Photonics, Ltd.
- Decided: Jun 4, 2002 after 90 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). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013043: Candela Clearbeam Pulsed Dye Laser, Candela Corp. (2001)
- K921842: Cynosure Photgenica V Cutaneous Vas. Lesion Laser, Cynosure, Inc. (1992) Summary page 1.

## Most influential descendants
- K032397: Dual Yellow Laser, Model Dual Yellow D10B (2004), 2 descendants of its own
- K132976: Advatx (2014), 1 descendant of its own
- K250189: AdvaTx (2025), 0 descendants of its own

## Indications for use
The NLite System laser system is indicated for use in Dermatological and Plastic Surgery applications and this device is intended for use in the treatment of Vascular lesions, such as :Port Wine Stains, Telangiectasia, Leg Veins, Spider Veins, Spider Naevus, Poikiloderma of civatte, Hemangiomas, Angiomas, Rosacea And benign cutaneous lesion, such as: Scars, Straie, Psoriasis, Verrucae Vulgaris and Warts.

Source page: https://510kreport.com/device/K020729
Methodology: https://510kreport.com/methodology