FDA.reportPublic FDA data

Array LaserLink

Primary DI
00810096330079
Brand
Array LaserLink
Company
Lumenis Be, Inc.
Model
NA
Published
2023-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151109000Lumenis Smart532 Laser SystemLumenis, Inc.2015-10-30GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810096330079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096330079008100963300798100963300790810096330079

GMDN Terms#

Term, Definition table
TermDefinition
Slit lamp/laser system control interfaceAn electrically-powered device assembly intended to be connected between a slit lamp and an ophthalmic laser system to facilitate adjustment of laser treatment settings (e.g., laser intensity, spot size and number, pattern parameters, laser beam positioning) during eye laser treatment. It consists of a laser delivery compartment designed to be attached to the slit lamp, a laser power control unit, a touchscreen, and a remote control (e.g., touchpad, 3-D mouse) which duplicates the functions of the laser system remote control.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118292380
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810096330246Endo kit with Fixed Eye Safety FilterEndo kit with Fixed ESF 532 nm2023-04-02
00810096330253Endo kit with Automatic Eye Safety FilterEndo kit with Auto ESF 532 nm2023-04-02
00810096330260Endo kit with Automatic Eye Safety FilterEndo kit with Auto 532/577/659 nm2023-04-02
00810096330277Endo kit with Fixed Eye Safety FilterEndo kit with Fixed 532/577/659 nm2023-04-02
00810096330284Automatic Eye Safety FilterAutomatic Eye Safety Filter 532nm2023-04-02
00810096330291Fixed Eye Safety FilterFixed Eye Safety Filter 532 nm2023-04-02
00810096330307Automatic Eye Safety FilterAutomatic Eye Safety Filter 532/577/659 nm2023-04-02
00810096330314Fixed Eye Safety FilterFixed Eye Safety Filter 532/577/659 nm2023-04-02
00810096330000Selecta Duet™Selecta Duet™2023-05-12
00810096330017Digital Duet™Digital Duet™2023-05-12
00810096330024Smart-V Illumination Add-onSmart-V Illumination Add-on2023-05-12
00810096330086Vision One G/Y/R2023-04-02
00810096330093Vision OneG/Y2023-04-02
00810096330109Vision OneGreen2023-04-02
00810096330116Vision One Red2023-04-02
00810096330123Vision OneG/R2023-04-02
00810096330130Vision One Y/R2023-04-02
00810096330147Vision OneYellow2023-04-02
00810096330062Smart532NA2023-04-02
00810096330215Smart LIONA2023-04-02

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