The following data is part of a premarket notification filed by Millennium Dental Technologies, Inc. with the FDA for Periolase Nd:yag Pulsed Dental Laser System.
| Device ID | K151763 |
| 510k Number | K151763 |
| Device Name: | PerioLase Nd:YAG Pulsed Dental Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MILLENNIUM DENTAL TECHNOLOGIES, INC. 10945 SOUTH ST., SUITE 104-A Cerritos, CA 90703 |
| Contact | David M Harris |
| Correspondent | David M Harris MILLENNIUM DENTAL TECHNOLOGIES, INC. 10945 SOUTH ST., SUITE 104-A Cerritos, CA 90703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-29 |
| Decision Date | 2016-03-15 |
| Summary: | summary |