NA

Primary DI
06951214400039
Brand
NA
Company
Chongqing Kanghuaruiming S&T Co., Ltd..
Model
SLM-3ER
Device description
The KH Ophthalmic Slit-lamp Microscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient’s eye through a control diaphragm a thin, intense beam of light. The KH Ophthalmic Slit-lamp Microscope is composed of the following components: microscope unit, illumination unit, base unit, chinrest, and table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient’s eyes, and also can observe the three-dimensional image.
Published
2018-03-22
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171877000SLM-1ER, SLM-2ER, SLM-3ERChongqing Kanghua Ruiming S&T Co., Ltd.2017-12-21HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06951214400039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951214400039069512144000396951214400039

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-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
543066376
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951214400015NASLM-1ER2018-03-21
06951214400022NASLM-2ER2018-03-21
06951214400077NAAPS-AER2018-03-22
06951214400084NAAPS-BER2018-03-22
06951214400091NAAPS-6000BER2018-03-22
06951214400107NAAPS-6000CER2018-03-22
06951214400213NAAPS-CER2018-03-22
06951214400220NAAPS-DER2018-03-22
06951214400237NAAPS-6000AER2018-03-22
06951214400244NAAPS-T302018-03-22
06951214400251NAAPS-T602018-03-22
06951214400268NAAPS-T902018-03-22
06951214400275NAAPS-T002018-03-22

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