Submission Details
| 510(k) Number | K180162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 19, 2018 |
| Decision Date | May 03, 2018 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Special
VivaScope System
May 2018
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K180162 is an FDA 510(k) clearance for the VivaScope System, a Light Based Imaging (Class II — Special Controls, product code PSN), submitted by Caliber Imaging & Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 3, 2018, 104 days after receiving the submission on January 19, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
Device Classification
| Product Code | PSN — Light Based Imaging |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |
| Definition | Emission And Collection Of Light To Create An Image For Medical Purposes |
Manufacturer
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