Cll- V1 Light Source
FDA 510(k) K130819 · Olympus Winter & Ibe GmbH
510(k) numberK130819
Submission
- Device name
- Cll- V1 Light Source
- Applicant
- Olympus Winter & Ibe GmbH
Center Valley, PA, US - Received
- March 25, 2013
- Decision date
- June 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTN – Led Light Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
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| K091829 | PLS Portable Light SourceNTN · Abbreviated | Optim, Inc. | 07/28/2009SE |
| K090601 | FSC 2NTN · Traditional | Schoelly Imaging, Inc. | 05/11/2009SE |
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Questions and answers
When was Cll- V1 Light Source cleared by the FDA?
Cll- V1 Light Source (K130819) received a 510(k) decision of Substantially Equivalent on June 19, 2013, 86 days after the submission was received.
What is the product code of K130819?
The FDA product code is NTN – Led Light Source, a Class II (moderate risk) device regulated under 21 CFR 876.1500.