# K050218: Wavelight Sinon

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: Feb 15, 2005 after 15 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 K910422 (1992). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040433: SINON, Wavelight Laser Technologie AG (2004) Summary page 1.
- K991285: Laser System Rubystar with Q-Switch and Normal Mode, Aesculap-Meditec North America (1999) Summary page 1.
- K910422: Model RD-1200 Ruby Laser System, Spectrum Medical Technologies, Inc. (1992) Summary page 1.
- K990902: Modification of MLT R694 Ruby Laser System, Medical Laser Technologies, Ltd. (1999)
- K971814: Improvements to the Mehl Ruby Laser, Mehl/Biophile Intl., Inc. (1997) Summary page 1.
- K040384: Mydon C, Wavelight Laser Technologie AG (2004) Summary page 1.

## Indications for use
1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions. 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

Source page: https://510kreport.com/device/K050218
Methodology: https://510kreport.com/methodology