The following data is part of a premarket notification filed by Fiberoptics Technology, Inc. with the FDA for Lo-50 Led Light Source.
| Device ID | K102167 |
| 510k Number | K102167 |
| Device Name: | LO-50 LED LIGHT SOURCE |
| Classification | Led Light Source |
| Applicant | FIBEROPTICS TECHNOLOGY, INC. 1 QUASSETT ROAD Pomfret, CT 06258 |
| Contact | Allan Guillotte |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-08-02 |
| Decision Date | 2010-08-17 |
| Summary: | summary |