FDA.reportPublic FDA data

SPECULAR MICROSCOPE SP-1P

Primary DI
04562123288315
Brand
SPECULAR MICROSCOPE SP-1P
Company
TOPCON CORPORATION
Model
SP-1P
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NQEMicroscope, specular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQEMicroscope, SpecularOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562123288315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562123288315045621232883154562123288315

GMDN Terms#

Term, Definition table
TermDefinition
Microscope still cameraAn electro-optical device designed to generate an enlarged photograph of a microscope field and its contents. This device is designed to utilize the lens system of the microscope in order to magnify the field. It may be attached to laboratory and/or surgical microscopes to document laboratory examinations and surgical procedures, respectively. Included are digital and photographic film cameras.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000MC-5S2025-12-09
04560126269188AUTO KERATO-REFRACTOMETER KR-1KR-12025-11-21
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATRK-32025-11-17
04560126269140AUTO KERATO-REFRACTOMETER KR-800KR-8002025-10-31
04560126269164AUTO REFRACTOMETER RM-800RM-8002025-10-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)3D OCT-12025-09-11
04571130283381AUTO KERATO-REFRACTOMETER KR-1KR-12025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PAKR-800PA2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosSNi-12025-05-01
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000SNi-12025-02-27
04571130283367AUTO KERATO-REFRACTOMETER KR-800AKR-800A2025-04-15
04562123288179COMPUTERIZED TONOMETER CT-80CT-802016-09-19
04560126268532COMPU VISION CV-5000CV-50002025-02-27
04560126268549COMPU VISION CV-5000CV-50002025-02-27
045601262685701DIAL CONTROLLER KB-50SKB-50S2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04571130282773REFRACTION SYSTEM ChronosChronos2024-08-01
04571130283350AUTO KERATO-REFRACTOMETER KR-800KR-8002024-05-09
04571130283374AUTO REFRACTOMETER RM-800RM-8002024-05-09

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
04582275250664NAKONAN MEDICAL, INC.NQE2022-04-07
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
04987669100530SPECULAR MICROSCOPENIDEK CO.,LTD.NQE2016-08-26