FDA.reportPublic FDA data

TAKAGI

Primary DI
04560323641121
Brand
TAKAGI
Company
TAKAGI SEIKO CO.,LTD.
Model
Slitlamp Microscope 700GL
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152535000Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd.2016-05-26HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560323641121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560323641121045603236411214560323641121

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. 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
690907167
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560323640940MARCOMARCO ULTRA M2 BI2024-03-14
04560323649165MARCOMARCO DELUXE STAND2023-09-08
04560323640902TAKAGIChart Projector CP-402023-06-09
04560323641114TAKAGISlitlamp Microscope 2ZL2023-06-09
04560323641176TAKAGISlitlamp Microscope 30GL2023-06-09
04560323641183TAKAGISlitlamp Microscope 4ZL2023-06-09
04560323643804TAKAGIPROJECTION PERIMETER MT 325UD2023-06-09
04560323648564TAKAGIAT-12023-06-09
04560323649158MARCOMARCO BRAVO STAND2023-06-09
04560323641138TAKAGIMobile Slit lamp MS12021-12-06
04560323648427MARCOMARCO ULTRA M52017-04-26
04560323648434MARCOMARCO ULTRA M22017-04-25
04560323648465MARCOMARCO ULTRA M42017-04-25
04560323648472MARCOMARCO ULTRA M32017-04-25
06909071671161MARCOMARCO G4 ULTRA SLITLAMP2016-08-23
06909071671178MARCOMARCO ULTRA2016-07-22
06909071671185MARCOMARCO 5 ULTRA SLITLAMP2016-08-26
06909071671192MARCOMARCO 2B ULTRA SLITLAMP2016-08-26
06909071671215MARCOMARCO G2 ULTRA SLITLAMP2016-08-26
06909071671222MARCOMARCO G5 ULTRA SLITLAMP2016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
04250668607202VISUREF 600Carl Zeiss Vision GmbHHJO2026-04-24
04049471097153SL 220Carl Zeiss Meditec AGHJO2026-01-13
00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
00819034023240TalarLiftFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520738PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520745PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520752PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520783PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520790PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520837DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520844DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520851Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520868Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520875LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520882Sgarlato SilasticFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520905PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520912PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007346Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08
04560323640940MARCOTAKAGI SEIKO CO.,LTD.HJO2024-03-14