FDA.reportPublic FDA data

Wave Light FS200 EASYPACK

Primary DI
00380650004529
Brand
Wave Light FS200 EASYPACK
Company
Alcon Laboratories, Inc.
Model
1515
Catalog number
8065000452
Device description
WaveLight FS200 EASYPACK Patient Interface (BOX OF 20)
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HNOKeratome, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380650004529PrimaryGS10
50380650004531Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650004529003806500045293806500045290380650004529
5038065000453150380650004531

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
20
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
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

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Primary DI, Brand, Company table
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