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510(k) K251781

KALA MINI 2.0 (KALA-04) by Shenzhen Kaiyan Medical Equipment Co., Ltd. — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
June 11, 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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