FDA.reportPublic FDA data

Digital Duet

Primary DI
07290109145181
Brand
Digital Duet
Company
LUMENIS INC.
Model
Selecta Duet Digital
Published
2021-03-22
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
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HQFLaser, OphthalmicOphthalmic2

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
07290109145181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109145181072901091451817290109145181

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical frequency-doubled solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.

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
07290109143637Smart-V Illumination Add-onSmart-V Illumination Add-on2022-03-23
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
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
08059173390038Olympus Empower H35 QUANTA SYSTEM SPAGEX2018-12-04
08059173390045Olympus Empower H65QUANTA SYSTEM SPAGEX2018-12-04
08057017760382DEKA SmartXide² TRIO C60HEL.EN. SPAGEX2018-11-26
08057017760399DEKA SmartXide² TRIO C80HEL.EN. SPAGEX2018-11-26
08033945938413Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938420Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938437Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938444Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938468Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938475Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2018-09-28