The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Sapphire St Portable Diode Laser.
| Device ID | K103667 |
| 510k Number | K103667 |
| Device Name: | SAPPHIRE ST PORTABLE DIODE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Contact | Alan B Matthews |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-15 |
| Decision Date | 2010-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813LR1001WINT0 | K103667 | 000 |