The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Medlite Laser System.
| Device ID | K955131 |
| 510k Number | K955131 |
| Device Name: | MEDLITE 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 | Laurie A Ridener |
| Correspondent | Laurie A Ridener 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 | 1995-11-09 |
| Decision Date | 1996-02-20 |