The following data is part of a premarket notification filed by Dental Photonics, Inc with the FDA for Stlase Diode Laser.
| Device ID | K094049 |
| 510k Number | K094049 |
| Device Name: | STLASE DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DENTAL PHOTONICS, INC 16 APPLETON ST Waltham, MA 02453 |
| Contact | Marcy Moore |
| Correspondent | Marcy Moore DENTAL PHOTONICS, INC 16 APPLETON ST Waltham, MA 02453 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-09-10 |
| Summary: | summary |