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510(k) K895864

Device
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
Applicant
LASAG AG
510(k) number
K895864
Product code
LXS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-29
Date received
1989-10-03
Regulation
886.4392
Classification name
Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MURRAY P HARRIS
Address
6440 Flying Cloud Dr., #117 Eden Prairie MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LXS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023045MICRORUPTER VMeridian AG2002-09-26
K901605PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.Phoenix Laser Systems, Inc.1990-12-13
K893987NIDEK MODEL YC-1200Nidek, Inc.1989-08-18
K892204NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERSNidek, Inc.1989-06-22
K892058ISL QC 2000Intelligent Surgical Lasers, Inc.1989-06-15

Legacy Summary#

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FDA Review#

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