FDA.reportPublic FDA data

NA

Primary DI
04582275250664
Brand
NA
Company
KONAN MEDICAL, INC.
Model
CellChek 20-1
Published
2022-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NQEMicroscope, specular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQEMicroscope, SpecularOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191558000Konan Specular Microscope XVIIKonan Medical, Inc.2020-03-26NQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275250664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275250664045822752506644582275250664

GMDN Terms#

Term, Definition table
TermDefinition
Eye anterior segment analyserA mains electricity (AC-powered) ophthalmic instrument intended to be used to measure and evaluate various properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber and lens). It is typically used for corneal topography, pachymetry, pupillometry and three-dimensional (3-D) analysis of the anterior eye segment using, e.g., revolving dual-channel Scheimpflug photography (viewing of the anterior segment in a sagittal plane) and Placido imaging (involves a disk with concentric white and black rings). It is typically computerized and provides output to a computer, with installed dedicated application software; the software may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690768619
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275250671NACellChek 20-1 PLUS2023-09-27
04582275250657NACC 20 rc2021-06-25
04582275250626NACellChek 202020-04-02
04582275250107NANSP2016-08-29
04582275250374NANSPC2016-09-23
04582275250404NACD-152016-09-23
04582275250428NACellchek2016-09-23
04582275250619N/APOM2017-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852194002007EB-3000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002021EB-2000xyzHightech American Industrial Labs IncNQE2025-12-25
00852194002014HAI CL-1000xyz clinical specular microscopeHightech American Industrial Labs IncNQE2025-03-21
04582275250671NAKONAN MEDICAL, INC.NQE2023-09-27
04582273603691SPECULAR MICROSCOPETOMEY CORPORATION.NQE2022-04-01
04582275250626NAKONAN MEDICAL, INC.NQE2020-04-02
04582273612822Specular MicroscopeTOMEY CORPORATION.NQE2018-03-06
04582275250374NAKONAN MEDICAL, INC.NQE2016-09-23
04582275250404NAKONAN MEDICAL, INC.NQE2016-09-23
04562123288315SPECULAR MICROSCOPE SP-1PTOPCON CORPORATIONNQE2016-09-19
04987669100530SPECULAR MICROSCOPENIDEK CO.,LTD.NQE2016-08-26