The following data is part of a premarket notification filed by Continuum Electro-optics, Inc. with the FDA for Medlite Q-swithced Laser.
| Device ID | K022709 |
| 510k Number | K022709 |
| Device Name: | MEDLITE Q-SWITHCED LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM ELECTRO-OPTICS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CONTINUUM ELECTRO-OPTICS, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-14 |
| Decision Date | 2003-02-20 |
| Summary: | summary |