The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Ceralas E/ 1470nm Fiber-coupled Diode Laser Family; Crealas Hpd Multiwavelenght 980nm/ 1470nm Fiber-coupled Diode Laser.
| Device ID | K102755 |
| 510k Number | K102755 |
| Device Name: | CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 515 SHAKER RD. East Longmeadow, MA 01028 |
| Contact | Nancy Foley |
| Correspondent | Nancy Foley 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 | 2010-09-23 |
| Decision Date | 2010-12-16 |
| Summary: | summary |