Led Light Phototherapy Bed (Pro 450/ GY-680A)
K-Number: K252786 · 2025-12-01
ApplicantShenzhen Suyzeko Limited.
Decision Date2025-12-01
Product CodeOLI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Led Light Phototherapy Bed (Pro 450/ GY-680A) is a medical device manufactured by Shenzhen Suyzeko Limited.. It received FDA 510(k) clearance on 2025-12-01 under approval number K252786. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Led Light Phototherapy Bed (Pro 450/ GY-680A)?
Led Light Phototherapy Bed (Pro 450/ GY-680A) is a medical device that received FDA 510(k) clearance on 2025-12-01. It is manufactured by Shenzhen Suyzeko Limited.. The 510(k) number is K252786.
When was Led Light Phototherapy Bed (Pro 450/ GY-680A) approved by the FDA?
Led Light Phototherapy Bed (Pro 450/ GY-680A) received FDA 510(k) clearance on 2025-12-01, under approval number K252786.
What company makes Led Light Phototherapy Bed (Pro 450/ GY-680A)?
Led Light Phototherapy Bed (Pro 450/ GY-680A) is manufactured by Shenzhen Suyzeko Limited..
What is the FDA product code for Led Light Phototherapy Bed (Pro 450/ GY-680A)?
The FDA product code for Led Light Phototherapy Bed (Pro 450/ GY-680A) is OLI.
Related Clinical Trials
Related Devices (Code: OLI)
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.