K251068 is an FDA 510(k) clearance for the KnoxFog Anti-fogging Device. This device is classified as a Anti Fog Solution And Accessories, Endoscopy (Class II - Special Controls, product code OCT).
Submitted by Uv One Hygienics, Inc. (Mesa, US). The FDA issued a Cleared decision on August 27, 2025, 142 days after receiving the submission on April 7, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens..
| 510(k) Number | K251068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2025 |
| Decision Date | August 27, 2025 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OCT - Anti Fog Solution And Accessories, Endoscopy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens. |