FDA.reportPublic FDA data

WAVELIGHT REFRACTIVE SUITE

Primary DI
00380650001108
Brand
WAVELIGHT REFRACTIVE SUITE
Company
Alcon Laboratories, Inc.
Model
8065000110
Device description
STAND ALONE PATIENT BED
Published
2021-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LZSExcimer laser system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZSExcimer Laser SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020050015

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020050015WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEMAlcon Laboratories, Inc.2003-10-07LZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380650001108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650001108003806500011083806500011080380650001108

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic chair, line-poweredA mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

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
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
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