EyeCaster

Basic Information

• Brand Name: EyeCaster
• Primary DI: 00860012447121
• Version / Model: BSI-14-HS-BQ900
• Company Name: Innovations Lightx Inc
• Labeler DUNS: 204229348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-12
• Public Version: 1
• Public Version Date: 2025-11-20
• Public Version Status: New
• Public Device Record Key: a135e07a-c45d-419c-b91f-f6fd02210c5c

Device Description

Slit-Lamp imaging for HS BQ900

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: Yes
• Has Lot/Batch Number: Yes
• 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
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	886.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62635	Smartphone camera ophthalmic imaging lens	An optical device intended to be attached over the camera lens of an off-the-shelf smartphone by a healthcare professional to enable imaging of the eye, including anterior segment and/or fundus, using the existing camera/video capabilities of the smartphone. It includes a lens and a smartphone-attachable portion, and may be intended for use with dedicated software (app). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012447121	GS1