AMA Optics Brightness Acuity Meter

Basic Information

• Brand Name: AMA Optics Brightness Acuity Meter
• Primary DI: G506BAM010
• Version / Model: GLARE-01-DEUCE
• Catalog Number: BAM01
• Company Name: AMA Optics, Inc.
• Labeler DUNS: 192827462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: dfe46e33-a265-4fc0-a970-514f69ffce13

Device Description

A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G506BAM010	HIBCC