OcuMet Beacon

Basic Information

• Brand Name: OcuMet Beacon
• Primary DI: G744OCUB100
• Version / Model: OCUB100
• Company Name: OcuSciences, Inc.
• Labeler DUNS: 800261849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-25
• Public Version: 2
• Public Version Date: 2026-04-13
• Public Version Status: Update
• Public Device Record Key: db468051-bdc5-4ec9-ae54-03e41f65c9f7

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
MYC	Ophthalmoscope, Laser, Scanning	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47952	Scanning-laser retinal imaging system	An assembly of electrically-powered ophthalmic instruments and digital image capturing/processing devices intended to use a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of choroiditis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G744OCUB100	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K241931	000