FDA.reportPublic FDA data

25ga Straight Laser Probe

Primary DI
VS01102517
Brand
25ga Straight Laser Probe
Company
Vortex Surgical, Inc.
Model
VS0110.25
Catalog number
VS0110.25
Device description
25ga Straight Laser Probe
Published
2020-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K191846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191846000MAXReach Laser ProbeVortex Surgical, Inc.2019-12-23HQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
VS01102517PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photocoagulation/photostimulationA mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended for: 1) ocular photocoagulation procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It typically includes a light source and controls/foot-switch, and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors; it may include a dosimetry sensor. It does not include femtosecond pulsing or fundus imaging technology.

Sterilization Methods#

Method table
Method

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