# K040433: SINON

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: May 19, 2004 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 K980187 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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). Our reading of the summary gave K990900, FDA’s number for Microkeratome, Model MK-2000 (Nidek, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MLT Laser Technologies Inc. MLT R694”.
- K971814: Improvements to the Mehl Ruby Laser, Mehl/Biophile Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- K050218: Wavelight Sinon (2005), 0 descendants of its own

## 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/K040433
Methodology: https://510kreport.com/methodology