COHERENT HOLMIUM:YAG SURGICAL LASER

Powered Laser Surgical Instrument

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Holmium:yag Surgical Laser.

Pre-market Notification Details

Device IDK895518
510k NumberK895518
Device Name:COHERENT HOLMIUM:YAG SURGICAL LASER
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 Received1989-09-12
Decision Date1989-11-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.