The following data is part of a premarket notification filed by Spectrum Medical Technologies, Inc. with the FDA for Model Rd-1200 Ruby Laser System.
| Device ID | K910422 |
| 510k Number | K910422 |
| Device Name: | MODEL RD-1200 RUBY LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRUM MEDICAL TECHNOLOGIES, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SPECTRUM MEDICAL TECHNOLOGIES, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-30 |
| Decision Date | 1992-04-21 |