K210925 is an FDA 510(k) clearance for the Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber, a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Boston Scientific (Marlborough, US). The FDA issued a Cleared decision on April 28, 2021, 30 days after receiving the submission on March 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K210925 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 2021 |
| Decision Date | April 28, 2021 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| 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. |