The following data is part of a premarket notification filed by Spectrum International with the FDA for Prometey, Model G1-03.
| Device ID | K062071 |
| 510k Number | K062071 |
| Device Name: | PROMETEY, MODEL G1-03 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRUM INTERNATIONAL 2643 PLEASANT HILL ROAD Pleasant Hill, CA 94523 |
| Contact | George I Bekov |
| Correspondent | George I Bekov SPECTRUM INTERNATIONAL 2643 PLEASANT HILL ROAD Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-09-28 |
| Summary: | summary |