Led Light Phototherapy Bed (Pro 450/ GY-680A)— 510(k) K252786

Name: FDA 510(k) clearance K252786
Creator: U.S. Food and Drug Administration
Published: 2025-12-01

Substantially Equivalent

Shenzhen Suyzeko Limited.

FDA 510(k) clearance K252786 for Led Light Phototherapy Bed (Pro 450/ GY-680A), Substantially Equivalent on 2025-12-01. Applicant: Shenzhen Suyzeko Limited.. Device class: 2.

Clearance details

Applicant: Shenzhen Suyzeko Limited.
Product code: Code OLI
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2025-09-02
Decision date: 2025-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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