20ga Curved Laser Probe - Alcon Compatible

Basic Information

• Brand Name: 20ga Curved Laser Probe - Alcon Compatible
• Primary DI: B384VS012020A1
• Version / Model: VS0120.20A
• Catalog Number: VS0120.20A
• Company Name: Vortex Surgical, Inc.
• Labeler DUNS: 080375891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-21
• Public Version Status: Update
• Public Device Record Key: 2e099c84-3936-4991-9f71-04e1f92b7e97

Device Description

20ga Curved Laser Probe- Alcon Compatible

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61162	Ophthalmic laser system beam guide	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B384VS012020A5	HIBCC	Box	10	In Commercial Distribution
Primary	B384VS012020A1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021696	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	20	Gauge