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
K252786Substantially Equivalent

Led Light Phototherapy Bed (Pro 450/ GY-680A)

Shenzhen Suyzeko Limited, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252786 is the FDA 510(k) clearance record for Led Light Phototherapy Bed (Pro 450/ GY-680A), a class II device, cleared for Shenzhen Suyzeko Limited. on under FDA product code OLI (Fat Reducing Low Level Laser). FDA's definition for product code OLI reads: "Non-invasive reduction in fat layer for body contouring". FDA records list one 510(k) clearance for Shenzhen Suyzeko Limited. As of , FDA records show no recalls naming K252786.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OLI Fat Reducing Low Level Laser
Regulation
21 CFR 878.5400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Suyzeko Limited. Rm. 301, Bldg. N, #17 Innovation Industrial Park, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLI

Trailing 12 months
5 clearances under product code OLI in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OLI, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260