The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Spphine Plus Stm 3w Diode Laser.
| Device ID | K110079 |
| 510k Number | K110079 |
| Device Name: | SPPHINE PLUS STM 3W DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Contact | Alan B Metthews |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-11 |
| Decision Date | 2011-02-10 |
| Summary: | summary |