The following data is part of a premarket notification filed by Continuum Electro-optics, Inc. with the FDA for Medlite Q-switched Nd:yag Laser Replaced By The Medlite C3 Q-swtiched Nd:yag Laser.
| Device ID | K011677 |
| 510k Number | K011677 |
| Device Name: | MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM ELECTRO-OPTICS, INC. 3150 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Contact | Ronald Kohlhardt |
| Correspondent | Ronald Kohlhardt CONTINUUM ELECTRO-OPTICS, INC. 3150 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-06-22 |
| Summary: | summary |