CureLight Medical Diode Laser Systems (CureLight F2-A15 +5 more— 510(k) K253965

Name: FDA 510(k) clearance K253965
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Substantially Equivalent

Wuhan 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.

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: Code ILY
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2025-12-11
Decision date: 2026-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.