The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Megabeam Reusable Fiber Optic Delivery System.
| Device ID | K113688 |
| 510k Number | K113688 |
| Device Name: | MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Granville, MA 01034 |
| Contact | Harry Hayes |
| Correspondent | Harry Hayes BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Granville, MA 01034 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-15 |
| Decision Date | 2012-03-13 |
| Summary: | summary |