K221770 is an FDA 510(k) clearance for the Fiber Laser Treatment System. This device is classified as a Powered Laser Surgical Instrument With Microbeamfractional Output (Class II - Special Controls, product code ONG).
Submitted by Shanghai Apolo Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 13, 2022, 114 days after receiving the submission on June 21, 2022.
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..
| 510(k) Number | K221770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2022 |
| Decision Date | October 13, 2022 |
| Days to Decision | 114 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. |