SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM

Powered Laser Surgical Instrument

CLINICON CORP.

The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Sureguide Co2 Laser Beam Delivery System.

Pre-market Notification Details

Device IDK992472
510k NumberK992472
Device Name:SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CLINICON CORP. 5825 AVENIDA ENCINAS, #101 Carlsbad,  CA  92008
ContactGerald S Palecki
CorrespondentGerald S Palecki
CLINICON CORP. 5825 AVENIDA ENCINAS, #101 Carlsbad,  CA  92008
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-26
Decision Date1999-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850013050185 K992472 000
00850013050178 K992472 000
00850013050161 K992472 000
00850013050154 K992472 000

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