LED Therapy Mask (MN1, M226)
K-Number: K242385 · 2025-04-07
ApplicantShenzhen Borria Technology Co., Ltd.
Decision Date2025-04-07
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LED Therapy Mask (MN1, M226) is a medical device manufactured by Shenzhen Borria Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under approval number K242385. 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 Therapy Mask (MN1, M226)?
LED Therapy Mask (MN1, M226) is a medical device that received FDA 510(k) clearance on 2025-04-07. It is manufactured by Shenzhen Borria Technology Co., Ltd.. The 510(k) number is K242385.
When was LED Therapy Mask (MN1, M226) approved by the FDA?
LED Therapy Mask (MN1, M226) received FDA 510(k) clearance on 2025-04-07, under approval number K242385.
What company makes LED Therapy Mask (MN1, M226)?
LED Therapy Mask (MN1, M226) is manufactured by Shenzhen Borria Technology Co., Ltd..
What is the FDA product code for LED Therapy Mask (MN1, M226)?
The FDA product code for LED Therapy Mask (MN1, M226) is OHS.
Other Devices by Shenzhen Borria Technology Co., Ltd.
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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.