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FDA 510(k)

HIGHERDOSE Red and Infrared Light Mask (MK66-L)

K-Number: K241933 · 2024-09-27

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2024-09-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-09-27 under approval number K241933. 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 HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K241933.

When was HIGHERDOSE Red and Infrared Light Mask (MK66-L) approved by the FDA?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) received FDA 510(k) clearance on 2024-09-27, under approval number K241933.

What company makes HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

The FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L) 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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