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510(k) K252568

New Day Skin Spray by Silk Holdings, Inc. — Product Code FRO

K252568 is an FDA 510(k) premarket notification submitted by Silk Holdings, Inc. for the device "New Day Skin Spray". The FDA issued a decision of Substantially Equivalent on January 23, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2026
Date Received
August 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources