FDA.reportPublic FDA data

WaveLight

Primary DI
00380659909634
Brand
WaveLight
Company
Alcon Laboratories, Inc.
Model
8065990963
Device description
WL ANALYZER II-USA
Published
2017-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZSExcimer laser system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZSExcimer Laser SystemUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380659909634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380659909634003806599096343806599096340380659909634

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic refractometer, automatedAn electrically-powered, automated, ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina) by measuring how light is changed when it enters the patient's eye(s). A beam of light is emitted from the device into the patient's eye and reflected back out where it is detected and measured for sphere, cylinder and axis, as well as high order aberration measurements; typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information, the device, also known as an aberrometer, will automatically calculate the lens prescription needed to correct the patient's vision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380659984372WaveLightAlcon Laboratories, Inc.LZS2025-03-12
04049471095074MEL 90 Carl Zeiss Meditec AGLZS2024-12-13
04050555004202TECHNOLAS TENEO 317Technolas Perfect Vision GmbHLZS2023-12-17
00380650001108WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2021-02-24
05050474620278IDESIGN RSJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2018-08-21
05050474651449IDESIGN RSJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2018-08-21
05050474651432IDESIGN RSJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2018-08-15
05050474651456IDESIGN RSJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2018-08-15
04987669101346Final FitNIDEK CO.,LTD.LZS2017-08-25
00380650004567WAVENETAlcon Laboratories, Inc.LZS2016-04-08
00380659908163WAVENETAlcon Laboratories, Inc.LZS2016-04-08
05050474591912IDESIGN ADVANCED WAVESCAN STUDIOJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2015-07-15
04987669100042Final Fit™NIDEK CO.,LTD.LZS2014-12-17
05050474573413STAR S4 IRJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-28
05050474573444WAVESCAN WAVEFRONT SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-20
05050474591905WAVESCAN OFFLINE PROGRAMMING MODULEJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2014-11-14
00380659906060WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
00380659907463WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
00380659907678WAVELIGHT ALLEGRO TOPOLYZERAlcon Laboratories, Inc.LZS2014-09-24
00380659907944WAVELIGHT EX500 EXCIMER LASERAlcon Laboratories, Inc.LZS2014-09-24
00380659908170WAVENETAlcon Laboratories, Inc.LZS2014-09-24
00380659908965WAVELIGHT REFRACTIVE SUITEAlcon Laboratories, Inc.LZS2014-09-24
04987669100011NANIDEK CO.,LTD.LZS2014-09-15
04987669100028Quest™NIDEK CO.,LTD.LZS2014-09-15
04987669100035Final Fit™NIDEK CO.,LTD.LZS2014-09-15
04049471000221MEL 80Carl Zeiss Meditec AGLZS2014-09-03