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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Suyzeko Limited.. It received FDA 510(k) clearance on 2025-12-01 under 510(k) 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. The listed applicant is Shenzhen Suyzeko Limited.. The 510(k) number is K252786.

When did Led Light Phototherapy Bed (Pro 450/ GY-680A) receive FDA 510(k) clearance?

Led Light Phototherapy Bed (Pro 450/ GY-680A) received FDA 510(k) clearance on 2025-12-01, under 510(k) number K252786.

Who is the listed applicant for Led Light Phototherapy Bed (Pro 450/ GY-680A)?

The FDA 510(k) record lists Shenzhen Suyzeko Limited. as the applicant. This does not by itself establish the device manufacturer.

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

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NCT07232667Digital Technology for Active and Healthy Ageing in TaiwanRECRUITING

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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