K251852 is an FDA 510(k) clearance for the cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200). This device is classified as a Confocal Optical Imaging (Class II - Special Controls, product code OWN).
Submitted by VPIX Medical, Inc. (Daejeon, KR). The FDA issued a Cleared decision on February 13, 2026, 241 days after receiving the submission on June 17, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Collection Of Light Signals For Visualization Of Cellular Microstructures..
| 510(k) Number | K251852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2025 |
| Decision Date | February 13, 2026 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWN - Confocal Optical Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Collection Of Light Signals For Visualization Of Cellular Microstructures. |