Device
The eye refractometer measures the objective refractive errors (including spherical, cylindrical refractive errors, cylinder axis) and corneal curvature radius of the patient’s eye...
Manufacturer
Chongqing Yeasn Science & Technology Co.,Ltd.
Chongqing Yeasn Science & Technology Co.,Ltd.
Model: YPC-100K
DI: 06971922136334
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Distribution End: 2029-12-31
Description
The eye refractometer measures the objective refractive errors (including spherical, cylindrical refractive errors, cylinder axis) and corneal curvature radius of the patient’s eye (including corneal refractive power, principle meridian directions, and corneal cylindrical power).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
678279db-c3b9-4ccb-a847-2d2f555971dc
Distribution Status:
In Commercial Distribution
DUNS Number:
547954649
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
Yes
Identifiers
Device ID:
06971922136334
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36386
Name: Automated ophthalmic refractometer
Definition:
An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.
FDA Product Codes
HKO
Refractometer, Ophthalmic