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FDA 510(k)

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

Número K: K260150 · 2026-04-22

RequerenteNOOANCE
Data da decisão2026-04-22
Código do produtoOHS
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is the device name listed in this FDA 510(k) record. The listed applicant is NOOANCE. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K260150. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is NOOANCE. The 510(k) number is K260150.

When did LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) receive FDA 510(k) clearance?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) received FDA 510(k) clearance on 2026-04-22, under 510(k) number K260150.

Who is the listed applicant for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

The FDA 510(k) record lists NOOANCE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

The FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is OHS.

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