# K050382: Affinity QS Q-Switched ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 14, 2005 after 211 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.
179 later devices descend from it; 3 cite it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medlite C6 Q-Switched Nd:YAG Laser system: named in the summary without a submission number

## Most influential descendants
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K073549: Q-Plus T (2008), 76 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own

## Indications for use
The Affinity QS Laser is intended for the treatment of vascular lesions, pigmented lesions, and for hair removal, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.

Source page: https://510kreport.com/device/K050382
Methodology: https://510kreport.com/methodology