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35 FDA 510(k) clearances · Product code

FDA profile

Official device name

Powered Laser Surgical Instrument With MicrobeamFractional Output

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Flags

Third-party review eligible

FDA definition

A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

Adverse events (MAUDE)

2015: 8 · 2017: 40 · 2018: 27 · 2019: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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