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FDA 510(k)

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Número K: K253965 · 2026-03-19

RequerenteWuhan PHOMED Technology Company , Ltd.
Data da decisão2026-03-19
Código do produtoILY
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan PHOMED Technology Company , Ltd.. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K253965. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)?

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Wuhan PHOMED Technology Company , Ltd.. The 510(k) number is K253965.

When did CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) receive FDA 510(k) clearance?

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) received FDA 510(k) clearance on 2026-03-19, under 510(k) number K253965.

Who is the listed applicant for CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)?

The FDA 510(k) record lists Wuhan PHOMED Technology Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)?

The FDA product code for CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) is ILY.

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Dispositivos Relacionados (Código: ILY)

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Fonte oficial

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