The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Megabeam Fiber Optic Delivery System With Additional Tips & Handpiece.
| Device ID | K113709 |
| 510k Number | K113709 |
| Device Name: | MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE |
| 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 | 2011-12-19 |
| Decision Date | 2012-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869851000382 | K113709 | 000 |
| 00859337007165 | K113709 | 000 |
| 00859337007134 | K113709 | 000 |
| 00859337007127 | K113709 | 000 |
| 00859337007110 | K113709 | 000 |
| 00859337007059 | K113709 | 000 |
| 00859337007073 | K113709 | 000 |
| 00869851000351 | K113709 | 000 |
| 00869851000368 | K113709 | 000 |
| 00869851000375 | K113709 | 000 |
| 00859337007158 | K113709 | 000 |