K253965 is an FDA 510(k) clearance for the CureLight Medical Diode Laser Systems (CureLight F2-A15. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Wuhan PHOMED Technology Company , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on March 19, 2026, 98 days after receiving the submission on December 11, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K253965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2025 |
| Decision Date | March 19, 2026 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |