FDA.reportPublic FDA data

Smart LIO

Primary DI
07290109140612
Brand
Smart LIO
Company
LUMENIS INC.
Model
NA
Published
2023-06-14
Public version status
Update
Distribution status
Not 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
K162837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162837000Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemLumenis, Ltd.2017-02-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109140612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109140612072901091406127290109140612

GMDN Terms#

Term, Definition table
TermDefinition
Indirect binocular laser ophthalmoscopeAn electrically-powered, head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043618763
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109143248Novus SpectraNovus Spectra2016-08-24
07290109143279Novus SpectraDual Port2016-08-24
07290109143293Smart532Smart5322016-10-10
07290109143316Selecta DuetSelecta Duet2016-08-25
07290109143835Smart LIONA2023-06-14
07290109143842Smart LIONA2023-06-14
07290109143637Smart-V Illumination Add-onSmart-V Illumination Add-on2022-03-23
07290109145181Digital DuetSelecta Duet Digital2021-03-22
07290109143255Selecta DuetSelecta Duet2016-08-24
07290109143262LaserLink SLaserLink S2016-08-25
07290109143286Vision OneVision One2016-08-25
07290109143309Selecta DuetSelecta Duet2016-08-16
07290109143378LIO KeelerLIO Keeler2016-09-11
07290109143385LaserLink ZLaserLink Z2016-08-31
07290109143392LaserLink ZLaserLink Z2016-08-31
07290109143446Automatic Eye Safety FilterAutomatic Eye Safety Filter2016-09-27
07290109143491LaserLink HSLaserLink HS2016-08-31
07290109143507Fixed Eye Safety FilterFixed Eye Safety Filter2016-11-27
07290109143545Array LaserLinkArray LaserLink2016-09-01
07290109143552Fixed Eye Safety FilterFixed Eye Safety Filter2016-09-25

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