The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Medlite Q-switched Nd:yag Laser, Medlite Iv Q-switched Nd: Yag Laser.
Device ID | K983054 |
510k Number | K983054 |
Device Name: | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin, CA 94568 |
Contact | Laurie A Ridener |
Correspondent | Laurie A Ridener CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin, CA 94568 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-01 |
Decision Date | 1999-02-10 |
Summary: | summary |