ARGON MICROSURIGAL PROTOCOLS

Laser, Ent Microsurgical Carbon-dioxide

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Argon Microsurigal Protocols.

Pre-market Notification Details

Device IDK810740
510k NumberK810740
Device Name:ARGON MICROSURIGAL PROTOCOLS
ClassificationLaser, Ent Microsurgical Carbon-dioxide
Applicant LUMENIS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEWG  
CFR Regulation Number874.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-19
Decision Date1981-08-21

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