K252787 is an FDA 510(k) clearance for the Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B), a Powered Laser Surgical Instrument (Class II — Special Controls, product code GEX), submitted by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 24, 2025, 83 days after receiving the submission on September 2, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K252787 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 2025 |
| Decision Date | November 24, 2025 |
| Days to Decision | 83 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. |