CureLight Medical Diode Laser Systems (CureLight F2-A15 +5 more— 510(k) K253965
Substantially EquivalentWuhan PHOMED Technology Company , Ltd.
FDA 510(k) clearance K253965 for CureLight Medical Diode Laser Systems (CureLight F2-A15 +5 more, Substantially Equivalent on 2026-03-19. Applicant: Wuhan PHOMED Technology Company , Ltd.. Device class: 2.
Summary
Wuhan PHOMED Technology's CureLight Medical Diode Laser Systems are filed under ILY, therapeutic heating infrared lamps. The name lists six models: F2-A15, F2-B15, F2-A30, F2-B30, F3-AB30 and F3-AB60.
Class II, 21 CFR 890.5500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel.
Wuhan PHOMED Technology filed from Wuhan, China. The decision came 98 calendar days after receipt (December 11, 2025 to March 19, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhan, CN
Recent devices under product code ILY
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.