The following data is part of a premarket notification filed by Optim Llc with the FDA for Precision Endoscopic Infrared Coagulator; Model 5100 Single-use Disposable Maxi-guide Flexible Lightguide; Model 5100-2.
| Device ID | K122593 |
| 510k Number | K122593 |
| Device Name: | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 |
| Classification | Electrode, Flexible Suction Coagulator |
| Applicant | OPTIM LLC 64 TECHNOLOGY PARK RD Sturbridge, MA 01566 |
| Contact | Jeff Barrett |
| Correspondent | Jeff Barrett OPTIM LLC 64 TECHNOLOGY PARK RD Sturbridge, MA 01566 |
| Product Code | FEH |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-24 |
| Decision Date | 2012-09-13 |
| Summary: | summary |