COHERENT XA-50, X30/CW, XA30/SP 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 Xa-50, X30/cw, Xa30/sp Surgical Lasers.

Pre-market Notification Details

Device IDK895143
510k NumberK895143
Device Name:COHERENT XA-50, X30/CW, XA30/SP 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 Received1989-08-18
Decision Date1989-09-25

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