HAI CL-1000xyz clinical specular microscope

GUDID 00852194002014

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.

Hightech American Industrial Labs Inc

Ophthalmic examination slit lamp

• Primary Device ID: 00852194002014
• NIH Device Record Key: de689f86-9665-4271-aed5-5356d317f407
• Commercial Distribution Discontinuation: 2025-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HAI CL-1000xyz clinical specular microscope
• Version Model Number: 1
• Company DUNS: 961991916
• Company Name: Hightech American Industrial Labs Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852194002014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994340

FDA Product Code

• NQE: Microscope, Specular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-31
• Device Publish Date: 2025-03-21