K192617 is an FDA 510(k) clearance for the Gemini 810+980 Soft Tissue Laser, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Azena Medical, LLC (Walnut Creek, US). The FDA issued a Cleared decision on February 20, 2020, 150 days after receiving the submission on September 23, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K192617 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2019 |
| Decision Date | February 20, 2020 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEX — Powered Laser Surgical Instrument |
| 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. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. 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. |