COHERENT XA30/SP AND XA50 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 Coherent Xa30/sp And Xa50 Surgical Lasers.

Pre-market Notification Details

Device IDK902470
510k NumberK902470
Device Name:COHERENT XA30/SP AND XA50 SURGICAL LASERS
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto,  CA  94303 -0810
ContactVirginia Singer
CorrespondentVirginia Singer
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 Received1990-06-04
Decision Date1990-07-26

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