FDA.reportPublic FDA data

STAR S4 IR

Primary DI
05050474573413
Brand
STAR S4 IR
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
0030-4864
Catalog number
0030-4864
Device description
ASSY, EXCIMER LASER SYSTEM,STAR S4 IR,
Published
2014-11-28
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
05050474573413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474573413050504745734135050474573413

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic excimer laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. It does not include femtosecond pulsing or fundus imaging technology.

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
05050474591912IDESIGN ADVANCED WAVESCAN STUDIOJOHNSON & JOHNSON SURGICAL VISION, INC.LZS2015-07-15
04987669100042Final Fit™NIDEK CO.,LTD.LZS2014-12-17
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