FDA 510(k)

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)

K-Number: K250966 · 2025-06-25

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.

Decision Date2025-06-25

Product CodeOHS

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250966. 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 CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)?

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250966.

When was CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) approved by the FDA?

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) received FDA 510(k) clearance on 2025-06-25, under approval number K250966.

What company makes CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)?

CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)?

The FDA product code for CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) is OHS.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING

Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Other Devices by Shenzhen Kaiyan Medical Equipment Co., Ltd.

K232863Radiant Renewal Skincare Wand (HD-15, HD-15A) K231321Nooance Led And Laser Helmet K242363HIGHERDOSE Red Light Hat (HG-120K) K241933HIGHERDOSE Red and Infrared Light Mask (MK66-L) K240089Face Patches (MT-12MA, MT-12MC) K233556LED Eye mask (EY-20R, A20, EY-20N)

View all 22 devices →

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.