The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Mega Beam/ceralas Nonsterile Collimating Handpiece.
| Device ID | K013193 |
| 510k Number | K013193 |
| Device Name: | MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 515 SHAKER RD. East Longmeadow, MA 01028 |
| Contact | Carol J Morello |
| Correspondent | Carol J Morello BIOLITEC, INC. 515 SHAKER RD. East Longmeadow, MA 01028 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-24 |
| Decision Date | 2001-12-21 |
| Summary: | summary |