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510(k) K254007

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) by SZ KKS Silicone&Electronic Co., Ltd. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2026
Date Received
December 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

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