Cleared Traditional

K192350 - Medical Non-Ablative Fractional Laser Systems (FDA 510(k) Clearance)

K192350 · Wingderm Electro-Optics , Ltd. · General & Plastic Surgery device
Apr 2020
Decision
245d
Days
Class 2
Risk

K192350 is an FDA 510(k) clearance for the Medical Non-Ablative Fractional Laser Systems. This device is classified as a Powered Laser Surgical Instrument With Microbeamfractional Output (Class II - Special Controls, product code ONG).

Submitted by Wingderm Electro-Optics , Ltd. (Beijing, CN). The FDA issued a Cleared decision on April 30, 2020, 245 days after receiving the submission on August 29, 2019.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. 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..

Submission Details

510(k) Number K192350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2019
Decision Date April 30, 2020
Days to Decision 245 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code ONG - Powered Laser Surgical Instrument With Microbeamfractional Output
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4810
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.