FDA 510(k)

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

Numéro K : K253878 · 2026-03-04

DemandeurShenzhen Kaiyan Medical Equipment Co., Ltd.

Date de décision2026-03-04

Code produitOLP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253878. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K253878.

When did LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) receive FDA 510(k) clearance?

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253878.

Who is the listed applicant for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

The FDA product code for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is OLP.

Essais cliniques associés

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Source officielle

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