Cleared Traditional

K202884 - SR-1 Skin Treatment System (FDA 510(k) Clearance)

K202884 · Avava, Inc. · General & Plastic Surgery device
Apr 2021
Decision
197d
Days
Class 2
Risk

K202884 is an FDA 510(k) clearance for the SR-1 Skin Treatment System. This device is classified as a Powered Laser Surgical Instrument With Microbeamfractional Output (Class II - Special Controls, product code ONG).

Submitted by Avava, Inc. (Waltham, US). The FDA issued a Cleared decision on April 13, 2021, 197 days after receiving the submission on September 28, 2020.

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 K202884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date April 13, 2021
Days to Decision 197 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.