FDA.reportPublic FDA data

IwavePhoropter

Primary DI
06971053610017
Brand
IwavePhoropter
Company
Krypton Vision (Suzhou) Ltd.
Model
IwavePhoropter
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
HKNRefractor, Manual, Non-Powered, Including Phoropter
HKORefractometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKNRefractor, Manual, Non-Powered, Including PhoropterOphthalmic1
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971053610017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971053610017069710536100176971053610017

GMDN Terms#

Term, Definition table
TermDefinition
PhoropterA mechanical ophthalmic device that is used during an ophthalmic examination; typically to determine a patient's prescription for glasses. It consists of two large, disk-like housings, joined together, that each contain a built-in paternoster works consisting of a large number of different lenses of differing strengths used to measure the refraction of the eye; it is a mechanized set of trial lenses. It is placed in front of the patient's eyes and viewing through the phoropter the patient is asked to read a Snellen eye chart placed at a preset distance. The optometrist changes the lenses and other settings, while asking the patient for subjective feedback on which settings give best vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543911771
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B43050086010GoCheck KidsGobiquity, Inc.HKO2026-06-25
06972039971092MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKO2026-06-03
06971922132299YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKN2026-05-01
06971922136334YEASNChongqing Yeasn Science & Technology Co.,Ltd.HKO2026-04-25
00628308210473S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210480LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210497S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210503LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210510S4OptikINNOVA Medical Ophthalmics IncHKN2026-03-31
00628308210527LombartINNOVA Medical Ophthalmics IncHKN2026-03-31
04987669203552Fully Assisted Refraction SystemNIDEK CO.,LTD.HKN2026-03-27
03615020000014AKR 550ESSILOR INTERNATIONALHKO2026-02-23
03615020000441AKR 800ESSILOR INTERNATIONALHKO2026-02-23
08800019600954Vision ScreenerHuvitz Co., Ltd.HKO2026-02-13
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HKO2026-01-08
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
B43071000030GoCheck MultiScreenerGobiquity, Inc.HKO2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
00860014277542S4 OptikLombart Brothers, Inc.HKN2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310429RexxamREXXAM CO., LTD.HKN2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17