The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Conbio-medlite(tm) Q-switched Nd:yag Laser System.
| Device ID | K922577 |
| 510k Number | K922577 |
| Device Name: | CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM BIOMEDICAL, INC. C/O BUCKMAN COMPANY, INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf CONTINUUM BIOMEDICAL, INC. C/O BUCKMAN COMPANY, INC. 1000 BURNETT AVENUE, STE. 450 Concord, CA 94520 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-01 |
| Decision Date | 1993-04-07 |