COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Family Of Co2 Surgical Laser Scanner Handpieces.

Pre-market Notification Details

Device IDK946304
510k NumberK946304
Device Name:COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
ContactAnne C Worden
CorrespondentAnne C Worden
LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-28
Decision Date1995-03-15

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