FDA.reportPublic FDA data

23ga Bending Laser Probe - Alcon Compatible

Primary DI
B384VS014023A5
Brand
23ga Bending Laser Probe - Alcon Compatible
Company
VORTEX SURGICAL, LLC
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
Rx
false
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080375891
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B384VS020023523ga Soft Tip CannulaVS0200.23VS0200.232016-11-30
B384VS020025525ga Soft Tip CannulaVS0200.25VS0200.252016-11-30
B384VS011020A520ga Straight Laser Probe - Alcon compatibleVS0110.20AVS0110.20A2016-09-24
B384VS011023A523ga Straight Laser Probe - Alcon CompatibleVS0110.23AVS0110.25A2016-09-24
B384VS011025A525ga Straight Laser Probe - Alcon CompatibleVS0110.25AVS0110.25A2016-09-24
B384VS012020A520ga Curved Laser Probe - Alcon CompatibleVS0120.20AVS0120.20A2016-09-24
B384VS012025A525ga Curved Laser Probe - Alcon CompatibleVS120.25AVS120.25A2016-09-24
B384VS012027A527ga Curved Laser Probe - Alcon CompatibleVS0120.27AVS0120.27A2016-09-24
B384012027I527ga Curved Laser Probe - Iridex CompatibleVS0120.27IVS0120.27I2016-09-24
B384VS013020A520ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.20AVS0130.20A2016-09-24
B384VS013023A523ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.23AVS0130.23A2016-09-24
B384VS013023I523ga Flexible Tapered Laser Probe - Iridex CompatiVS0130.23IVS0130.23I2016-09-24
B384VS013025A525ga Flexible Tapered Laser Probe - Alcon CompatibVS0130.25AVS0130.25A2016-09-24
B384VS013025I525ga Flexible Tapered Laser Probe - Iridex CompatiVS0130.25IVS0130.25I2016-09-24
B384VS014020A520ga Bending Laser Probe - Alcon CompatibleVS0140.20AVS0140.20A2016-09-24
B384VS014023I523ga Bending Laser Probe - Iridex CompatibleVS0140.23IVS0140.23I2016-09-24
B384VS014025A525ga Bending Laser Probe - Alcon CompatibleVS0140.25AVS0140.25A2016-09-24
B384VS014025I525ga Bending Laser Probe - Iridex CompatibleVS0140.25IVS0140.25I2016-09-24
B384VS030023523ga Edge Advantage ILM ElevatorVS0300.23VS300.232016-11-30
B384VS030025525ga Edge Advantage ILM ElevatorVS0300.25VS0300.252016-11-30

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