ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER

Powered Laser Surgical Instrument

COHERENT MEDICAL GROUP

The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Ultrapulse(tm) Carbon Dioxide Surgical Laser.

Pre-market Notification Details

Device IDK912029
510k NumberK912029
Device Name:ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
ContactVirginia Singer
CorrespondentVirginia Singer
COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto,  CA  94303
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-07
Decision Date1991-08-13

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