REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM

Powered Laser Surgical Instrument

HOYA CONBIO, INC

The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Revlite C6 Q-switched Nd:yag Laser System.

Pre-market Notification Details

Device IDK063834
510k NumberK063834
Device Name:REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant HOYA CONBIO, INC 1105 SUNSET CREEK LANE Pleasanton,  CA  94566
ContactDonna Templeman
CorrespondentDonna Templeman
HOYA CONBIO, INC 1105 SUNSET CREEK LANE Pleasanton,  CA  94566
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-26
Decision Date2007-01-25
Summary:summary

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