cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)— 510(k) K251852
Substantially EquivalentVPIX Medical, Inc.
FDA 510(k) clearance K251852 for cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200), Substantially Equivalent on 2026-02-13. Applicant: VPIX Medical, Inc.. Device class: 2.
Summary
VPIX Medical's cCeLL - In vivo with Drop-In Robo lists three designations: CN100-2W2C488775, CN100-1W1C775, and DR200. It's filed under product code OWN, confocal optical imaging, and the record doesn't say how they differ.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology, Urology as the classification panel.
VPIX Medical filed from Daejeon, South Korea. The decision came 241 calendar days after FDA received it (June 17, 2025 to February 13, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- VPIX Medical, Inc.
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Recent devices under product code OWN
view allMore clearances from VPIX Medical, Inc.
view allAdverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.