Device
The VS Tabletop Tonometer (model name: IOP 100) is a digital tonometer used to measure intraocular pressure of the eye. The VS Tabletop Tonometer is designed to be used by patients...
Manufacturer
MEDIMAGING INTEGRATED SOLUTION INC.
MEDIMAGING INTEGRATED SOLUTION INC.
Model: 1802
DI: 04719872711230
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
The VS Tabletop Tonometer (model name: IOP 100) is a digital tonometer used to measure intraocular pressure of the eye. The VS Tabletop Tonometer is designed to be used by patients in clinic settings under professional guidance.
The intended purpose of the device as an adjunct is to support routine monitoring of eye pressure in the clinic to better understand the eye condition. This device should not be solely or primarily relied upon to prevent, diagnose, or treat ocular conditions.
The VS Tabletop Tonometer features an alignment system that positions itself before taking an IOP measurement. Once properly aligned, the device automatically makes an IOP measurement. Measurements are made using an air puff, without any physical object contacting the eye. The VS Tabletop Tonometer is powered by a rechargeable Li-ion battery.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3c01d006-743d-4163-97a6-d103ac7cf7c9
Distribution Status:
In Commercial Distribution
DUNS Number:
656813438
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
04719872711230
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 67414
Name: Ophthalmic tonometer, professional
Definition:
An ophthalmic, electrically-powered device intended to be used by a healthcare professional to measure intraocular pressure (IOP) by exerting an external force against the eye, which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation), typically for the diagnosis of glaucoma. It may have a light contact with the eye, have a bench-top or hand-held design, and use various techniques (e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air).
FDA Product Codes
HKX
Tonometer, Ac-Powered