The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for 180w Cerelas D 980nm Diode Laser, Model D180.
| Device ID | K083682 |
| 510k Number | K083682 |
| Device Name: | 180W CERELAS D 980NM DIODE LASER, MODEL D180 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BIOLITEC, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-01-09 |
| Summary: | summary |