COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Ultrapulse S Series Co2 Surgical Lasers Model C And L.

Pre-market Notification Details

Device IDK974789
510k NumberK974789
Device Name:COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
ContactMichele Deeton
CorrespondentMichele Deeton
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 Received1997-12-22
Decision Date1998-03-09
Summary:summary

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