MEDLITE LASER SYSTEM

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 Laser System.

Pre-market Notification Details

Device IDK952636
510k NumberK952636
Device Name:MEDLITE LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CONTINUUM BIOMEDICAL, INC. 1000 BURNETT AVE. SUITE 250 Concord,  CA  94520
ContactLaurie A Ridener
CorrespondentLaurie A Ridener
CONTINUUM BIOMEDICAL, INC. 1000 BURNETT AVE. SUITE 250 Concord,  CA  94520
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-08
Decision Date1995-07-31

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