YEASN

Primary DI
06971922135030
Brand
YEASN
Company
Chongqing Yeasn Science & Technology Co.,Ltd.
Model
YF-100
Device description
For eye examination and aid in the diagnosis.Contraindications: none.Target groups of patients: adults, children.Intended users: optometrists in hospital ophthalmology and optical shops.The people who use this product are ophthalmologists in hospitals or clinics, and optometrists in optical shops. To operate this product, they should have relevant knowledge of eye examinations and have the relevant skills to operate the product.
Published
2022-07-27
Public version status
Update
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
K161764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161764000SLIT LAMP, Model: YF-100Chongqing Yeasn Science-Technology Co., Ltd.2017-02-16HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971922135030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971922135030069719221350306971922135030

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
547954649
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971922132299YEASNYPA-2100S2026-05-01
06971922133319YEASNYPB-2100P2026-05-01
06971922136334YEASNYPC-100K2026-04-25
06971922132770YEASNSLY-1002025-04-08
06971922132558YEASNMPH150MPH1502024-11-30
06971922132787YEASNMPH150MPH150BN2024-11-30
06971922132794YEASNMPH150MPH150BP2024-11-30
06971922136037YEASNYPC-1002024-08-21
06971922131070YEASNCCQ-800CCQ8/102022-04-21
06971922132725YEASNSLY-100SLY1/392022-04-21
06971922133029YEASNYPB-2100YPB21/12022-04-21
06971922131377YEASNCCQ1100CCQ11/22022-03-05
06971922132046Digital RefractorYPA-2100YPA21/32021-11-29
06971922130097FocimeterCCQ-4002021-03-03
06971922130103FocimeterCCQ-5002021-03-03
06971922130110Auto FocimeterCCQ-11002021-03-03
06971922130042Auto FocimeterCCQ-8002020-10-22
06971922130066LCD Visual ChartYPB-21002020-10-22
06971922130073Digital RefractorYPA-21002020-10-22
06971922130080PupilometerHX-4002020-10-22

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