FDA.reportPublic FDA data

20ga Straight Laser Probe - Alcon compatible

Primary DI
B384VS011020A5
Brand
20ga Straight Laser Probe - Alcon compatible
Company
VORTEX SURGICAL, LLC
Model
VS0110.20A
Catalog number
VS0110.20A
Device description
20ga Straight 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
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K02169600020G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25Ophthalmed, LLC2002-08-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B384VS011020A5PackageHIBCC10In Commercial Distribution
B384VS011020A1PrimaryHIBCC0

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 Gauge20Gauge

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
true
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
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
B384VS014023A523ga Bending Laser Probe - Alcon CompatibleVS0140.23AVS0140.23A2016-09-24
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

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