FDA.reportPublic FDA data

WaveLight

Primary DI
00380659908194
Brand
WaveLight
Company
Alcon Laboratories, Inc.
Model
8065990819
Device description
Wavelight FS200 Patient intereface
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOEOphthalmic femtosecond laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOEOphthalmic Femtosecond LaserOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10380659908191PackageGS120Not in Commercial Distribution
00380659908194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038065990819110380659908191
00380659908194003806599081943806599081940380659908194

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, single-useA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration 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
00850062486027LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000167LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000174LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000181ALLYLENSAR, Inc.OOE2026-04-13
00380650009449LenSxAlcon Laboratories, Inc.OOE2025-10-01
04050555002086Patient Interface 125 KitTechnolas Perfect Vision GmbHOOE2024-03-13
00867744000150ALLYLENSAR, Inc.OOE2023-08-18
10867744000157ALLYLENSAR, LLCOOE2023-08-18
05050474655690INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474655706INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474738553ELITAJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
07640167750573FEMTOSIE AG, Surgical Instrument EngineeringOOE2022-06-10
07640167751334Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751341Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751358Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751365Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751372Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751389Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
05050474709508CATALYS SYSTEMOPTIMEDICA CORPORATIONOOE2020-08-19
07640167750511Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750528Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750542Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750566Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750580Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750603Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750627Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751051Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751068Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751082Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751143Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14