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510(k) K163632

Device
Katalyst Cyclophotocoagulation Probe
Applicant
Katalyst Surgical, LLC
510(k) number
K163632
Product code
LQJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-15
Date received
2016-12-22
Regulation
886.4390
Classification name
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Meryl Koch
Address
754 Goddard Ave. Chesterfield MO US 63005 63005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931356SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTORSorenson Laboratories, Inc.1993-09-07
K921414TROKEL /3 GONIO LASER LENSOcular Instruments, Inc.1992-11-16
K912112PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480Tomey Corporation USA1991-06-17
K893731SHIELDS T.C. LASER LENSOcular Instruments, Inc.1989-08-17
K884694MQL 20 ND:YAG OPHTHALMIC LASERCalifornia Laboratories, Inc.1988-11-30
K883719INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEMBiophysic Medical, Inc.1988-10-18
K883270IRIS ND:YAG OPTHALMIC LASERCalifornia Laboratories, Inc.1988-10-13
K882574BOLDREY PERIPHERAL RETINAL LENSOcular Instruments, Inc.1988-07-29
K872802TROKEL SINGLE MIRROR YAG LASER LENSOcular Instruments, Inc.1987-09-04
K871245LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1Chiron Vision Corp.1987-05-07
K871099SCHIRMER NYLON SUTURE LASER LENSOcular Instruments, Inc.1987-04-27
K862869PETRUS SINGLE MIRROR LASER LENSOcular Instruments, Inc.1986-08-21

Legacy Summary#

summary

FDA Review#

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