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
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
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
08717872014203Directional Laser Probe with Alcon / Lumenis connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014968Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014975Directional Laser Probe with DORC connector.(20 gauge / 0.9 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872014982Directional Laser Probe with DORC connector.(23 gauge / 0.6 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031781EVA NEXUS™ Infusion Giving SetD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031798EVA NEXUS™ Irrigation and Aux. Aspiration TubingD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
08717872031897Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm)D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HQF2022-07-01
1081748902371320ga Curved Illuminated Laser Probe, 19ga Needle Illumination, IridexKATALYST SURGICAL LLCHQF2020-11-28
1081748902372020ga Curved Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-28
1081748902373720ga Curved Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-28
1081748902374420ga Curved Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-28
1081748902375120ga Curved Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-28
1081748902376823ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902377523ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902378223ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902379923ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902380523ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902381225ga Flexible Tapered Illuminated Laser Probe, Iridex CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902382925ga Flexible Tapered Illuminated Laser Probe, Alcon CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902383625ga Flexible Tapered Illuminated Laser Probe, Quantel CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902384325ga Flexible Tapered Illuminated Laser Probe, Nidek CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902385025ga Flexible Tapered Illuminated Laser Probe, DORC CompatibleKATALYST SURGICAL LLCHQF2020-11-28
1081748902357720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27
1081748902358420ga Straight Illuminated Laser Probe, 19ga Needle Illumination, QuantelKATALYST SURGICAL LLCHQF2020-11-27
1081748902359120ga Straight Illuminated Laser Probe, 19ga Needle Illumination, NidekKATALYST SURGICAL LLCHQF2020-11-27
1081748902360720ga Straight Illuminated Laser Probe, 19ga Needle Illumination, DORCKATALYST SURGICAL LLCHQF2020-11-27
1081748902362123ga Straight Illuminated Laser Probe, 19ga Needle Illumination, AlconKATALYST SURGICAL LLCHQF2020-11-27