K102167 is an FDA 510(k) clearance for the LO-50 LED LIGHT SOURCE, a Led Light Source (Class II — Special Controls, product code NTN), submitted by Fiberoptics Technology, Inc. (Pomfret, US). The FDA issued a Cleared decision on August 17, 2010, 15 days after receiving the submission on August 2, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K102167 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2010 |
| Decision Date | August 17, 2010 |
| Days to Decision | 15 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 |