The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Evolve Hpd 980/ 1470nm Multiwavelength Diode Laser (evolve Dual).
| Device ID | K120231 |
| 510k Number | K120231 |
| Device Name: | EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Granville, MA 01034 |
| Contact | Harry Hayes, Ph.d |
| Correspondent | Harry Hayes, Ph.d BIOLITEC MEDICAL DEVICES, 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 | 2012-01-25 |
| Decision Date | 2012-04-24 |
| Summary: | summary |