MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Modified Coherent Ultrapulse Co2 Surgical Lasers.

Pre-market Notification Details

Device IDK951812
510k NumberK951812
Device Name:MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
ContactAnne Worden
CorrespondentAnne 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 Received1995-04-19
Decision Date1995-07-07

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