Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows: 1410 nm Indications for Use: * Fractional skin resurfacing procedures 1927 nm Indications for Use: * Fractional skin resurfacing procedures LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously: * Fractional skin resurfacing procedures
The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows: 1410 nm Indications for Use: * Fractional skin resurfacing procedures 1927 nm Indications for Use: * Fractional skin resurfacing procedures LPTT (Laser Polytherapy Treatment) application of 1410 nm and 1927 nm simultaneously: * Fractional skin resurfacing procedures.
The Lumenis YandR Laser System consists of: • System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts) • Operator control panel with touch-screen technology (GUI) • NAFR handpiece and single-use removable tips • Footswitch and other laser safety accessories. The non-ablative fractional NAFR handpiece emits two wavelengths – 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.
Summary parsed at:2026-06-01 05:38:18 UTC
