K253965
- 510(k) number
- K253965
- Device name
- CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
- Applicant
- Wuhan PHOMED Technology Company , Ltd. CN
- Product code
- ILY — Lamp, Infrared, Therapeutic Heating
- Decision date
- 2026-03-19
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
510(k) Summary (official FDA PDF): K253965.pdf
Official FDA record: K253965
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.