The following data is part of a premarket notification filed by Spectrum Medical Technologies, Inc. with the FDA for Rd-1200h Normal Mode Ruby Laser System.
| Device ID | K955612 |
| 510k Number | K955612 |
| Device Name: | RD-1200H NORMAL MODE RUBY LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRUM MEDICAL TECHNOLOGIES, INC. 3499 WOODLEY PARK PL. Ovideo, FL 32765 |
| Contact | Robert T Handren |
| Correspondent | Robert T Handren SPECTRUM MEDICAL TECHNOLOGIES, INC. 3499 WOODLEY PARK PL. Ovideo, FL 32765 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-07-09 |
| Summary: | summary |