K252568 is an FDA 510(k) clearance for the New Day Skin Spray. This device is classified as a Dressing, Wound, Drug.
Submitted by Silk Holdings, Inc. (Needham, US). The FDA issued a Cleared decision on January 23, 2026, 162 days after receiving the submission on August 14, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K252568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2025 |
| Decision Date | January 23, 2026 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |