Model: YZ3
DI: 06951090800978
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Distribution End: 2026-04-27
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c8f5ee66-2049-4b75-ad5d-65087863c9a4
Distribution Status:
Not in Commercial Distribution
DUNS Number:
544800253
Device Count:
1
DM Exempt:
Yes
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06951090800978
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35148
Name: Ophthalmic examination slit lamp
Definition:
An electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).
FDA Product Codes
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
Premarket Submissions
Submission Number:
K131711
Supplement Number:
000