The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Evolve(r) Hpd 980/1470nm Multiwavelength Diode Laser.
| Device ID | K112013 |
| 510k Number | K112013 |
| Device Name: | EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER |
| 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 | 2011-07-14 |
| Decision Date | 2012-01-13 |
| Summary: | summary |