FDA.reportPublic FDA data

Slit Lamp HS-7500

Primary DI
08800019600077
Brand
Slit Lamp HS-7500
Company
Huvitz Co., Ltd.
Model
HS-7500(LED)
Catalog number
HS-7500(LED)
Device description
""" -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)"" -. The SLIT LAMP is intended for use in eye examination of the anterior eye segments, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment."
Published
2019-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K093639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093639000SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500Huvitz Co., Ltd.2009-12-03HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019600077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600077088000196000778800019600077

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

Contacts#

Phone, Email table
PhoneEmail
+82314289100svc@huvitz.com

Regulatory Flags#

DUNS number
688154202
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800019600121Imaging System HIS-5000UHIS-5000UHIS-5000U2019-05-10
08800019600954Vision ScreenerHVS-12026-02-13
08800019600992Auto Ref-Topographer HRKT-1HRKT-12026-01-30
08800019601074Visual Acuity Chart System HDC-100HDC-1002025-11-19
08800019601005LilivisLS-100-TIP-3R2025-09-08
08800019600794Huvitz Integrated Image Server HIIS-1HIIS-12025-08-14
08800019600961OCTiX IntraOral ScannerLSO-100Y4XXCL-24-000012024-11-26
00880019600961Lilivis SCAN OPTOMOLSO-100Y4XXCL-24-000012024-11-26
08800019600978Instrument Table CIT-4100CIT-41002024-06-24
08800019600985Instrument Table CIT-4200CIT-42002024-06-24
08800019600893Lilivis Scan LS-100LS-100LS-1002024-05-27
08800019600909Lilivis CAD L-CADL-CADLS-1002024-05-27
08800019600411Applanation Tonometer HT-5000HT-5000HT-50002023-06-12
08800019600787Optical Biometer HBM-1HBM-12023-10-18
08800019600916Digital Refractor HDR-7100PHDR-7100P2023-08-24
08800019600923Auto Ref/Keratometer HRK-8100AHRK-8100A2023-08-24
08800019600435Non-contact Tonometer HNT-1PHNT-1PHNT-1P2023-06-12
08800019600503Ref-Keratometer ERK-9100ERK-9100ERK-91002023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHTR-1AHTR-1A2023-06-12
08800019600732Digital Chart HDC-9100NHDC-9100NHDC-9100N2023-06-12

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