FDA.reportPublic FDA data

EyeCaster

Primary DI
00860012447121
Brand
EyeCaster
Company
Innovations Lightx Inc
Model
BSI-14-HS-BQ900
Device description
Slit-Lamp imaging for HS BQ900
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012447121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012447121008600124471218600124471210860012447121

GMDN Terms#

Term, Definition table
TermDefinition
Smartphone camera ophthalmic imaging lensAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
204229348
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012447107EclipseCLP-142025-11-12
00860012447138EyeCasterBSI-14-HS-BP9002025-11-12
00860012447145EyeCasterBSI-14-UN2025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010859193OptaseScope Health Inc.PJZ2026-05-01
00860014277559MarcoLombart Brothers, Inc.PJZ2026-03-02
06430046260993Optomed Lumo Camera setOptomed OyPJZ2025-11-13
00860012447138EyeCasterInnovations Lightx IncPJZ2025-11-12
00860012447145EyeCasterInnovations Lightx IncPJZ2025-11-12
06973211070619Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071500Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
06973211071517Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2025-08-18
00850067214229identifeye Camera System, tabletIdentifeye Health Inc.PJZ2025-07-07
00850067214236identifeye Camera System, power supplyIdentifeye Health Inc.PJZ2025-07-07
00850067214274identifeye Camera SystemIdentifeye Health Inc.PJZ2025-07-07
00850067214281identifeye Camera System, reconditionedIdentifeye Health Inc.PJZ2025-07-07
06976107790301AirdocChangsha Airdoc Health Technology Co., Ltd.PJZ2024-09-27
07908616100097Eyer 2 BasicPHELCOM TECHNOLOGIES SAPJZ2024-09-23
00860011978305EntireEye PortableRETIVUE, LLCPJZ2024-07-18
00811608014708Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00811608014739Volk VivaVOLK OPTICAL INC.PJZ2024-04-05
00860010826812Oivi Opthalmic Fundus CameraOivi ASPJZ2024-01-15
00853501008002Spect Ophthalmic CameraSpect Inc.PJZ2023-08-10
10860000249543Verily Retinal CameraVERILY LIFE SCIENCES LLCPJZ2023-05-24
07908616100042EyerPHELCOM TECHNOLOGIES SAPJZ2023-04-27
08056389701405ME-CHECK 4ESPANSIONE MARKETING SPAPJZ2023-04-05
00811608013770Volk VistaViewVOLK OPTICAL INC.PJZ2022-11-16
00850038195229Eli EzerU.S. OPHTHALMIC, L.L.C.PJZ2022-11-03
06945087500088MediworksSHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.PJZ2022-11-02
00628678036017WRI-1Cellview Imaging Inc.PJZ2022-09-08
00628678036055WRI-1Cellview Imaging Inc.PJZ2022-09-08
06973211070008Fundus CameraCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPJZ2022-06-08
08906096520052RemidioREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDPJZ2022-01-31
18437014903024HD AnalyzerVISIOMETRICS SLPJZ2022-01-21