FDA.reportPublic FDA data

Smart-V Illumination Add-on

Primary DI
07290109143637
Brand
Smart-V Illumination Add-on
Company
LUMENIS INC.
Model
Smart-V Illumination Add-on
Published
2022-03-23
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
K081704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081704000SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMSLumenis, Inc.2008-09-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109143637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109143637072901091436377290109143637

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser systemAn electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology.

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
07290109140612Smart LIONA2023-06-14
07290109143835Smart LIONA2023-06-14
07290109143842Smart LIONA2023-06-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14