# K103539: Quanta System Duolite

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jan 20, 2011 after 49 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 K050382 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050382: Affinity QS Q-Switched ND:Yag Laser System, Cynosure, Inc. (2005) Summary page 1.

## Indications for use
Nd:YAG (1064nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo) Nd:YAG (532nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

Source page: https://510kreport.com/device/K103539
Methodology: https://510kreport.com/methodology