The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Ceralas E 980nm Diode Laser, Models E15/980 And E30/980.
| Device ID | K082263 |
| 510k Number | K082263 |
| Device Name: | CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 |
| 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 | 2008-08-08 |
| Decision Date | 2008-10-24 |
| Summary: | summary |