The following data is part of a premarket notification filed by Continuum Electro-optics, Inc. with the FDA for Medlite Iv Q-switchednd: Yaglaser Replaced By The Medlite C6 Q-swicthed Nd: Yag Laser.
| Device ID | K014234 |
| 510k Number | K014234 |
| Device Name: | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED 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 | 2001-12-26 |
| Decision Date | 2002-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494103354 | K014234 | 000 |
| 00841494103637 | K014234 | 000 |
| 00841494100322 | K014234 | 000 |
| 00841494100315 | K014234 | 000 |
| 00841494100209 | K014234 | 000 |
| 00841494100193 | K014234 | 000 |