Vision One

Basic Information

• Brand Name: Vision One
• Primary DI: 00810096330093
• Version / Model: G/Y
• Company Name: Lumenis Be, Inc.
• Labeler DUNS: 118292380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-02
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 153b86b4-a47d-4f8a-9c50-3ce946aa44b0

Device Characteristics

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

Sterilization

• Is Sterile: No
• 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
62161	Ophthalmic diode laser system	An electrically-powered device assembly in which input energy is used to excite a diode to emit a low-power and/or high-power therapeutic laser beam intended for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy, vitrectomy). Some types may also include an air pump to disperse subretinal fluid in certain procedures (e.g. retinal detachment repair). The laser utilizes a diode/semiconductor chip (as the active medium); it does not include femtosecond pulsing, or fundus imaging technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810096330093	GS1

Premarket Submissions

Submission Number	Supplement Number
K111213	000