K241916 is an FDA 510(k) clearance for the TearRepair Liquid Skin Protectant. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Optmed, Inc. (New York, US). The FDA issued a Cleared decision on September 27, 2024, 88 days after receiving the submission on July 1, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K241916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KMF - Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |