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510(k) K253878

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) by Shenzhen Kaiyan Medical Equipment Co., Ltd. — Product Code OLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2026
Date Received
December 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Powered Light Based Laser For Acne
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

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