The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Ceralas D 980nm Diode Laser, Models D15 And D25.
| Device ID | K081015 |
| 510k Number | K081015 |
| Device Name: | CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 -5910 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 -5910 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-09 |
| Decision Date | 2008-07-08 |
| Summary: | summary |