K221268 is an FDA 510(k) clearance for the SR-1 Skin Treatment System, 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 November 21, 2022, 203 days after receiving the submission on May 2, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K221268 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 02, 2022 |
| Decision Date | November 21, 2022 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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. |