Auto Lensmeter HLM-9000

Basic Information

• Brand Name: Auto Lensmeter HLM-9000
• Primary DI: 08800019600404
• Version / Model: HLM-9000
• Catalog Number: HLM-9000
• Company Name: Huvitz Co., Ltd.
• Labeler DUNS: 688154202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-10
• Public Version: 1
• Public Version Date: 2019-05-20
• Public Version Status: New
• Public Device Record Key: 29df3338-869b-4e7d-a5fb-1f28b834474b

Device Description

Lensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	886.1425	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12326	Manually-adjusted lensmeter, line-powered	A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800019600404	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]