MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER

Powered Laser Surgical Instrument

CONTINUUM BIOMEDICAL, INC.

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.

Pre-market Notification Details

Device IDK983054
510k NumberK983054
Device Name:MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER
ClassificationPowered Laser Surgical Instrument
Applicant CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin,  CA  94568
ContactLaurie A Ridener
CorrespondentLaurie A Ridener
CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin,  CA  94568
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-01
Decision Date1999-02-10
Summary:summary

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