SINON

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K040433 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Wavelight Auriga

  Class II

  FDA 510(k) K051399 Active Cleared 30 Jun 2005

• Wavelight Sinon

  Class II

  FDA 510(k) K050218 Active Cleared 15 Feb 2005

• Arion

  Class II

  FDA 510(k) K042474 Active Cleared 29 Sep 2004

• Burane XL

  Class II

  FDA 510(k) K050317 Active Cleared 24 Feb 2005

• Mydon C

  Class II

  FDA 510(k) K040384 Active Cleared 14 May 2004

• Burane

  Class II

  FDA 510(k) K052806 Active Cleared 17 Oct 2005

See all devices from Wavelight Laser Technologie AG →

• What is the SINON laser system used for?

  The SINON is a Class 2 laser system designed for precision and efficiency in general and plastic surgery procedures. It is manufactured by Wavelight Laser Technologie AG and intended for use in surgical settings requiring laser technology.

• What regulatory approvals does the SINON laser system have?

  The SINON laser system received FDA 510(k) clearance through the Traditional pathway on May 19, 2004, with K number K040433. It is classified under product code GEX for General & Plastic Surgery devices.

• How is the SINON laser system supplied and what are its storage requirements?

  The device is supplied as a complete laser system for surgical use. While specific storage requirements aren't detailed in the provided information, medical laser systems typically require controlled temperature and humidity environments to maintain optimal performance and safety.

• Is the SINON laser system reusable or single-use?

  The SINON is a laser system designed for multiple procedures rather than single-use. As a Class 2 medical device, it would be intended for repeated use in clinical settings following proper sterilization and maintenance protocols according to manufacturer guidelines.