The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Ceralas 147nm Diode Laser System.
| Device ID | K112253 |
| 510k Number | K112253 |
| Device Name: | CERALAS 147NM DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 1349 MAIN ROAD Granville, MA 01034 |
| Contact | Harry Hayes |
| Correspondent | Harry Hayes BIOLITEC, 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 | 2011-08-05 |
| Decision Date | 2011-09-20 |
| Summary: | summary |