V-RASER DIODE 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 V-raser Diode Laser System.

Pre-market Notification Details

Device IDK073332
510k NumberK073332
Device Name:V-RASER DIODE LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte,  CA  95383
ContactLiza Burns
CorrespondentLiza Burns
HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte,  CA  95383
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-27
Decision Date2008-02-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.