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FDA 510(k)

LED LIGHT MASK (A093)

K-Number: K250880 · 2025-06-20

ApplicantFoshan Guangyu Weilai Medical Equipment Co., Ltd.
Decision Date2025-06-20
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED LIGHT MASK (A093) is a medical device manufactured by Foshan Guangyu Weilai Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K250880. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED LIGHT MASK (A093)?

LED LIGHT MASK (A093) is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Foshan Guangyu Weilai Medical Equipment Co., Ltd.. The 510(k) number is K250880.

When was LED LIGHT MASK (A093) approved by the FDA?

LED LIGHT MASK (A093) received FDA 510(k) clearance on 2025-06-20, under approval number K250880.

What company makes LED LIGHT MASK (A093)?

LED LIGHT MASK (A093) is manufactured by Foshan Guangyu Weilai Medical Equipment Co., Ltd..

What is the FDA product code for LED LIGHT MASK (A093)?

The FDA product code for LED LIGHT MASK (A093) is OHS.

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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.

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