The following data is part of a premarket notification filed by Spectrum Medical Technologies, Inc. with the FDA for Epilaser Normal Mode Ruby Laser.
| Device ID | K963947 |
| 510k Number | K963947 |
| Device Name: | EPILASER NORMAL MODE RUBY LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRUM MEDICAL TECHNOLOGIES, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Sanford Lane |
| Correspondent | Sanford Lane SPECTRUM MEDICAL TECHNOLOGIES, INC. 45 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-03-05 |
| Summary: | summary |