IwavePhoropter

Basic Information

• Brand Name: IwavePhoropter
• Primary DI: 06971053610017
• Version / Model: IwavePhoropter
• Company Name: Krypton Vision (Suzhou) Ltd.
• Labeler DUNS: 543911771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-23
• Public Version: 3
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 78ffb60d-ff50-410a-b014-bbbb31983819

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	886.1770	1
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35299	Phoropter	An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971053610017	GS1