APEX 800 LASER SYSTEM, MODEL APEX 800

Powered Laser Surgical Instrument

IRIDEX CORP.

The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Apex 800 Laser System, Model Apex 800.

Pre-market Notification Details

Device IDK020849
510k NumberK020849
Device Name:APEX 800 LASER SYSTEM, MODEL APEX 800
ClassificationPowered Laser Surgical Instrument
Applicant IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
ContactJohn D'angelo
CorrespondentJohn D'angelo
IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-15
Decision Date2002-05-20
Summary:summary

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