HAI CL-1000xyz clinical specular microscope

Basic Information

• Brand Name: HAI CL-1000xyz clinical specular microscope
• Primary DI: 00852194002014
• Version / Model: 1
• Company Name: Hightech American Industrial Labs Inc
• Labeler DUNS: 961991916
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-21
• Public Version: 1
• Public Version Date: 2025-03-31
• Public Version Status: New
• Public Device Record Key: de689f86-9665-4271-aed5-5356d317f407
• Distribution End Date: 2025-03-28

Device Description

HAI CL-1000xyz is the clinical contact specular microscope. It evaluates the patient cornea endothelial cell layer. It is Class II, NQE medical device. In 2000, FDA notified that HAI CL-1000xyz received the 510(k) number K994340.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQE	Microscope, Specular	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35148	Ophthalmic examination slit lamp	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852194002014	GS1

Premarket Submissions

Submission Number	Supplement Number
K994340	000