FDA 510(k)

LED Facial Mask

K-Number: K213056 · 2022-07-07

ApplicantShenzhen Osto Technology Company Limited

Decision Date2022-07-07

Product CodeOLP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LED Facial Mask is a medical device manufactured by Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2022-07-07 under approval number K213056. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2022-07-07. It is manufactured by Shenzhen Osto Technology Company Limited. The 510(k) number is K213056.

When was LED Facial Mask approved by the FDA?

LED Facial Mask received FDA 510(k) clearance on 2022-07-07, under approval number K213056.

What company makes LED Facial Mask?

LED Facial Mask is manufactured by Shenzhen Osto Technology Company Limited.

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OLP.

Other Devices by Shenzhen Osto Technology Company Limited

K190673Health Expert Electronic Stimulator K190783Health Expert Electronic Stimulator (model: AST-300L) K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) K211736Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H

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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.