FDA.reportPublic FDA data

SPECULAR MICROSCOPE

Primary DI
04582273603691
Brand
SPECULAR MICROSCOPE
Company
TOMEY CORPORATION.
Model
EM-4000
Published
2022-04-01
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
K171313000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171313000EM-4000 Specular MicroscopeTomey Corporation2018-01-19NQE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582273612822PreviousGS10
04582273603691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582273612822045822736128224582273612822
04582273603691045822736036914582273603691

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
696280002
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582273604704Cornea/Anterior Segment OCTCASIA22023-06-07
04582273612822Specular MicroscopeEM-40002018-03-06
04582273600218AUTO REFKERATOMETERRC-50002022-04-01
04582273600256AUTO REF-TOPOGRAPHERRT-70002022-04-01
04582273600263NON-CONTACT TONOMETERFT-10002022-04-01
04582273603714Topographic Modeling SystemTMS-4N2022-04-01
04582273604162Auto LensmeterTL-70002022-04-01
04582273611788AUTO REFKERATOMETERRC-8002022-04-01
04582273612679Auto LensmeterTL-60002022-04-01
04582273612242AUTO REFKERATOMETERRC-50002020-10-30
04582273612273AUTO REFKERATOMETERRC-8002020-10-30
04582273612297AUTO REF-TOPOGRAPHERRT-70002020-10-30
04582273612099TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612129TOPOGRAPHIC MODELING SYSTEMTMS-4N2020-10-30
04582273612402AUTO LENSMETERTL-1002020-10-30
04582273612655AUTO LENSMETERTL-70002020-10-30
04582273612686AUTO LENSMETERTL-60002020-10-30
04582273612167NON-CONTACT TONOMETERFT-10002016-10-18
04582273611740NON-CONTACT TONOMETERFT-10002016-10-18
04582273612150NON-CONTACT TONOMETERFT-10002016-09-21

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
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