Device
Portable Meibographer for the storage of images of the eye and surrounding area (meibomian glands).
Manufacturer
Scope Health Inc.
Scope Health Inc.
Model: MX2
Catalog: FRUSMX2
DI: 00860010859193
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Portable Meibographer for the storage of images of the eye and surrounding area (meibomian glands).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1768aa9a-f7b1-49e4-8c0e-0d7137b52b7d
Distribution Status:
In Commercial Distribution
DUNS Number:
116778693
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860010859193
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62592
Name: Meibomian gland camera
Definition:
A mains electricity (AC-powered) optical device intended for infrared (IR) image capture of the meibomian glands for evaluation of structural abnormalities of the meibomian glands. It includes patient head/chin supports, an IR source(s), IR camera, controls and appropriate software intended to enable analysis of the images; it may include an eyelid everter to assist imaging of the meibomian glands.
FDA Product Codes
PJZ
Camera, Ophthalmic, General-Use