FDA.reportPublic FDA data

WAVENET

Primary DI
00380650004567
Brand
WAVENET
Company
Alcon Laboratories, Inc.
Model
8065000456
Device description
WAVENET PLANNING SOFTWARE
Published
2016-04-08
Public version status
Update
Distribution status
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
00380650004567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650004567003806500045673806500045670380650004567

GMDN Terms#

Term, Definition table
TermDefinition
Laser application softwareAn individual software program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a laser for storing, processing, and managing electronic information/data used during a treatment with a laser. It is typically installed in a laser and/or interfaced with an ordinary computer (e.g., tabletop, laptop) which displays the data.

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Serial number
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
00380659909634WaveLightAlcon Laboratories, Inc.LZS2017-09-13
04987669101346Final FitNIDEK CO.,LTD.LZS2017-08-25
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