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FDA 510(k)

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

K-Number: K253878 · 2026-03-04

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2026-03-04
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K253878.

When was LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) approved by the FDA?

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

What company makes LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)?

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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