FDA.reportPublic FDA data

23ga Bending Laser Probe - Alcon Compatible

Primary DI
B384VS014023A1
Brand
23ga Bending Laser Probe - Alcon Compatible
Company
Vortex Surgical, Inc.
Model
VS0140.23A
Catalog number
VS0140.23A
Device description
23ga Bending Laser Probe - Alcon Compatible
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142830000Ophthalmed Bending Laser ProbesOphthalmed, LLC2015-06-25HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B384VS014023A5PackageHIBCC10In Commercial Distribution
B384VS014023A1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge23Gauge

Contacts#

Phone, Email table
PhoneEmail
636-778-4350info@vortexsurgical.com

Regulatory Flags#

DUNS number
080375891
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810123481842Vortex Surgical Inc.VS0752.232025-04-18
00810123481859Vortex Surgical Inc.VS0752.252025-04-18
00810123482320Vortex Surgical Inc.VS0753.232025-04-18
00810123482344Vortex Surgical Inc.VS0753.252025-04-18
00810123482399Vortex Surgical Inc.VS0751.232025-04-18
00810123482405Vortex Surgical Inc.VS0751.252025-04-18
00810123482795Vortex Surgical Inc.VS0751.272025-04-18
00810123482818Vortex Surgical Inc.VS0753.272025-04-18
00810123482887Vortex Surgical Inc.VS0752.272025-04-18
00810123483167Vortex Surgical Inc.VS08032025-04-18
00810123483617Vortex Surgical Inc.VS0135.252025-04-18
00810123483624Vortex Surgical Inc.VS0135.232025-04-18
00810123483631Vortex Surgical Inc.VS0125.232025-04-18
00810123483648Vortex Surgical Inc.VS0125.252025-04-19
00810123483662Vortex Surgical Inc.VS03902025-04-18
00810123481828Vortex Surgical Inc.VS0752.232025-04-18
00810123481835Vortex Surgical Inc.VS0752.252025-04-18
00810123482313Vortex Surgical Inc.VS0753.232025-04-18
00810123482337Vortex Surgical Inc.VS0753.252025-04-18
00810123482382Vortex Surgical Inc.VS0751.232025-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M735A5026001NAOPHTHALMED LLCHQB2022-09-22
M735A5027001NAOPHTHALMED LLCHQB2022-09-22
M735A5036001NAOPHTHALMED LLCHQB2022-09-22
M735A5037001NAOPHTHALMED LLCHQB2022-09-22
13700773703743FLEX CURVED LASER PROBE COMPATIBLE WITH Iridex / Bausch & Lomb™ 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703750FLEX CURVED LASER PROBE COMPATIBLE WITH Alcon® / Coherent / Zeiss / Ellex / OS4®FCI S A S FCI 20 22HQB2021-05-30
13700773703767CURVED LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773703774FLEX CURVED LASER PROBE COMPATIBLE WITH NIDEK THREAD 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773703781FLEX CURVED LASER PROBE COMPATIBLE WITH DORC 27 G FCI S A S FCI 20 22HQB2021-05-30
13700773720047STRAIGHT LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720054STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720061STRAIGHT LASER PROBE, 20G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720078STRAIGHT LASER PROBE, 20G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720085STRAIGHT LASER PROBE, 20G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720092STRAIGHT LASER PROBE, 23G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720108STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720115STRAIGHT LASER PROBE, 23G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720122STRAIGHT LASER PROBE, 23G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720139STRAIGHT LASER PROBE, 23G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720146STRAIGHT LASER PROBE, 25G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720153STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720160STRAIGHT LASER PROBE, 25G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720177STRAIGHT LASER PROBE, 25G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720184STRAIGHT LASER PROBE, 25G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720191STRAIGHT LASER PROBE, 27G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30
13700773720207STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4FCI S A S FCI 20 22HQB2021-05-30
13700773720214STRAIGHT LASER PROBE, 27G QUANTELFCI S A S FCI 20 22HQB2021-05-30
13700773720221STRAIGHT LASER PROBE, 27G NIDEKFCI S A S FCI 20 22HQB2021-05-30
13700773720238STRAIGHT LASER PROBE, 27G DORCFCI S A S FCI 20 22HQB2021-05-30
13700773720245CURVED LASER PROBE, 20G IRIDEX/B&LFCI S A S FCI 20 22HQB2021-05-30