The following data is part of a premarket notification filed by Spectragenics, Inc. with the FDA for Spectra Pulsed Diode Laser, Model Dr-1.
| Device ID | K032846 |
| 510k Number | K032846 |
| Device Name: | SPECTRA PULSED DIODE LASER, MODEL DR-1 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRAGENICS, INC. 7083 COMMERCE CIRCLE SUITE 1 Pleasanton, CA 94588 |
| Contact | Robert E Grove |
| Correspondent | Robert E Grove SPECTRAGENICS, INC. 7083 COMMERCE CIRCLE SUITE 1 Pleasanton, CA 94588 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2003-12-11 |
| Summary: | summary |