Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LED Facial Mask

K-Number: K243978 · 2025-06-20

ApplicantShenzhen Sunsred Technology Co.,Ltd
Decision Date2025-06-20
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Facial Mask is a medical device manufactured by Shenzhen Sunsred Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-06-20 under approval number K243978. 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 Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Shenzhen Sunsred Technology Co.,Ltd. The 510(k) number is K243978.

When was LED Facial Mask approved by the FDA?

LED Facial Mask received FDA 510(k) clearance on 2025-06-20, under approval number K243978.

What company makes LED Facial Mask?

LED Facial Mask is manufactured by Shenzhen Sunsred Technology Co.,Ltd.

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OHS.

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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.

↑