K130819 is an FDA 510(k) clearance for the CLL- V1 LIGHT SOURCE. This device is classified as a Led Light Source (Class II — Special Controls, product code NTN).
Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on June 19, 2013, 86 days after receiving the submission on March 25, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals.
| 510(k) Number | K130819 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2013 |
| Decision Date | June 19, 2013 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NTN — Led Light Source |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals |