ClearanceBrief
Product code LZS ยท Class 3

Excimer Laser System

0510(k)s in 12 months (0 all time)
0recalls in 12 months (29 all time)
0recalls that name a 510(k)
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Top companies in LZS

Company510(k)sRecalls
AMO Manufacturing USA, LLC013
Abbott Medical Optics, Inc.07
Nidek Inc03
VISX INCORPORATED, A SUBSIDIARY OF AMO INC03
Alcon Laboratories, Inc.01
Alcon Refractive Horizons, Inc.01
Visx Inc01
DateFirm and productCodeLinked 510(k)
Oct 21, 2021AMO Manufacturing USA, LLC
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Open, Classified
LZSNone listed
Feb 1, 2017Nidek Inc
Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of th
Terminated
LZSNone listed
Jun 4, 2015Nidek Inc
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for corre
Terminated
LZSNone listed
Nov 17, 2014Nidek Inc
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam del
Terminated
LZSNone listed
Oct 22, 2013Abbott Medical Optics, Inc.
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated
Terminated
LZSNone listed
Oct 22, 2013Abbott Medical Optics, Inc.
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer
Terminated
LZSNone listed
Oct 22, 2013Abbott Medical Optics, Inc.
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are
Terminated
LZSNone listed
Oct 22, 2013Abbott Medical Optics, Inc.
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated
Terminated
LZSNone listed
Jun 13, 2013Abbott Medical Optics, Inc.
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in
Terminated
LZSNone listed
Jun 13, 2013Abbott Medical Optics, Inc.
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicate
Terminated
LZSNone listed
Jun 13, 2013Abbott Medical Optics, Inc.
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.30 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.20 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.16 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.10 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.02 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.01 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Aug 9, 2011AMO Manufacturing USA, LLC
STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shi
Terminated
LZSNone listed
Feb 18, 2011AMO Manufacturing USA, LLC
AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Ver
Terminated
LZSNone listed
Sep 17, 2008VISX INCORPORATED, A SUBSIDIARY OF AMO INC
AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefron
Terminated
LZSNone listed
Aug 20, 2008VISX INCORPORATED, A SUBSIDIARY OF AMO INC
Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated
Terminated
LZSNone listed
Jun 5, 2008VISX INCORPORATED, A SUBSIDIARY OF AMO INC
AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051
Terminated
LZSNone listed
Jan 23, 2008Visx Inc
Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
Terminated
LZSNone listed
Jun 5, 2007Alcon Refractive Horizons, Inc.
LADAR6000 Excimer Laser System
Terminated
LZSNone listed
Jun 21, 2006Alcon Laboratories, Inc.
LADARVision Excimer Laser System.
Terminated
LZSNone listed

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