New Day Skin Spray
K-Number: K252568 · 2026-01-23
ApplicantSilk Holdings, Inc.
Decision Date2026-01-23
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
New Day Skin Spray is a medical device manufactured by Silk Holdings, Inc.. It received FDA 510(k) clearance on 2026-01-23 under approval number K252568. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the New Day Skin Spray?
New Day Skin Spray is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Silk Holdings, Inc.. The 510(k) number is K252568.
When was New Day Skin Spray approved by the FDA?
New Day Skin Spray received FDA 510(k) clearance on 2026-01-23, under approval number K252568.
What company makes New Day Skin Spray?
New Day Skin Spray is manufactured by Silk Holdings, Inc..
What is the FDA product code for New Day Skin Spray?
The FDA product code for New Day Skin Spray is FRO. This falls under the Anesthesiology category.
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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.