510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K253878Substantially Equivalent

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

Shenzhen Kaiyan Medical Equipment Co., Ltd, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253878 is the FDA 510(k) clearance record for LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001), a class II device, cleared for Shenzhen Kaiyan Medical Equipment Co., Ltd. on under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne). FDA's definition for product code OLP reads: "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...". FDA records list 24 510(k) clearances for Shenzhen Kaiyan Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K253878.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OLP Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd. Bldg.#3 And Bldg.#5, 40th Of Fuxin St., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLP

Trailing 12 months
1 clearance under product code OLP in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260