FDA.reportPublic FDA data

IDESIGN ADVANCED WAVESCAN STUDIO

Primary DI
05050474591912
Brand
IDESIGN ADVANCED WAVESCAN STUDIO
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
G300
Catalog number
0110-2261
Device description
IDESIGN ADVANCED WAVESCAN STUDIO US
Published
2015-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
05050474591912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474591912050504745919125050474591912

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(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
010130626
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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
00380650004567WAVENETAlcon Laboratories, Inc.LZS2016-04-08
00380659908163WAVENETAlcon Laboratories, Inc.LZS2016-04-08
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