MINI-HALO CO2 LASER SYSTEM

Powered Laser Surgical Instrument

COOPERVISION, INC.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Mini-halo Co2 Laser System.

Pre-market Notification Details

Device IDK843915
510k NumberK843915
Device Name:MINI-HALO CO2 LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant COOPERVISION, INC. P.O. BOX 19587 Irvine ,  CA  92713 -
ContactDouglas G Allen
CorrespondentDouglas G Allen
COOPERVISION, INC. P.O. BOX 19587 Irvine ,  CA  92713 -
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-04
Decision Date1985-05-10

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