meddevicedb.com FDA Device Reference

New Day Skin Spray

K252568 Traditional
Decision Date
2026-01-23
Sponsor / Applicant
Silk Holdings, Inc.

Technical Specification

510(k) Submission ID K252568
Product Code FRO
Medical Specialty / Panel Unknown
Decision Date 2026-01-23
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

New Day Skin Spray received FDA 510(k) clearance under submission number K252568, sponsored by Silk Holdings, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-01-23.

Classification & Regulation

This clearance is catalogued under FDA product code FRO , within the Unknown review panel as a device.