The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Conbio Medlite Q-switched Nd:yag Laser System.
| Device ID | K915497 |
| 510k Number | K915497 |
| Device Name: | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM BIOMEDICAL, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose CONTINUUM BIOMEDICAL, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-03-06 |