FDA.reportPublic FDA data

Selecta Duet™

Primary DI
00810096330000
Brand
Selecta Duet™
Company
Lumenis Be, Inc.
Model
Selecta Duet™
Published
2023-05-12
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
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220877000Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.2022-07-15HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810096330000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096330000008100963300008100963300000810096330000

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
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
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
00810096330079Array LaserLinkNA2023-04-02
00810096330215Smart LIONA2023-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10757770060464Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060471Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
10757770060488Bausch + LombBausch & Lomb IncorporatedHQF2026-04-09
08717872036526EVA Cartridge with 0.5 L Collection BagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036489EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036496EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036502EVA Nexus™ Irrigation TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036618EVA Nexus™ Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872036625EVA NEXUS™ cartridge with 0,5 L collection bagD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2025-03-31
08717872034713CUSTOM TDC VITREC.PACK VGP 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-09-27
08717872034652EVA Vitrectomy Pack VGPC Input 20GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034683EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034690EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872034706EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-20
08717872032672EVA Custom TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032702EVA Custom TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2024-02-15
08717872032122EVA Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032139EVA Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032146EVA Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032153EVA Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032160EVA TDC Vitrectomy Pack Gravity Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032177EVA TDC Vitrectomy Pack VGPC Input 23GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032184EVA TDC Vitrectomy Pack Gravity Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032191EVA TDC Vitrectomy Pack VGPC Input 25GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032221EVA TDC Vitrectomy Pack Gravity Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872032238EVA TDC Vitrectomy Pack VGPC Input 27GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-12-08
08717872034430EVA NEXUS™, Phaco vitrectomy system including laser with DORC connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872034447EVA NEXUS™, Phaco vitrectomy system including laser with SMA connectorD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-08-01
08717872014142Directional Laser Probe with Alcon / Lumenis connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014173Directional Laser Probe with Alcon / Lumenis connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01