FDA.reportPublic FDA data

Auto Lensmeter HLM-7000P

Primary DI
08800019600459
Brand
Auto Lensmeter HLM-7000P
Company
Huvitz Co., Ltd.
Model
HLM-7000P
Catalog number
HLM-7000P
Device description
Lensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens
Published
2019-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLMInstrument, Measuring, Lens, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLMInstrument, Measuring, Lens, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019600459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019600459088000196004598800019600459

GMDN Terms#

Term, Definition table
TermDefinition
Manually-adjusted lensmeter, line-poweredA mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688154202
Device count
1
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04540008320138RexxamREXXAM CO., LTD.HLM2026-04-20
04540008320145RexxamREXXAM CO., LTD.HLM2026-04-20
04540008320152RexxamREXXAM CO., LTD.HLM2026-04-20
04987669204924AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
04987669204979AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
04987669205020AUTO LENSMETERNIDEK CO.,LTD.HLM2026-04-20
00860014277535S4Optik AL 2000 Digital LensmeterLombart Brothers, Inc.HLM2025-10-18
03664188000602VISIONIXLUNEAU TECHNOLOGY OPERATIONSHLM2025-09-05
00812559012270LensChekPlusREICHERT, INC.HLM2025-08-12
00812559012287LensChekProREICHERT, INC.HLM2025-08-12
08034028770524TOPCONVISIA IMAGING SRLHLM2025-02-20
06971922131292YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2024-08-08
04562123288384COMPUTERIZED LENSMETER CL-300TOPCON CORPORATIONHLM2023-12-19
04562123288391COMPUTERIZED LENSMETER CL-300TOPCON CORPORATIONHLM2023-12-19
03615020000038ALM500ESSILOR INTERNATIONALHLM2023-10-03
03615020000120ALM700ESSILOR INTERNATIONALHLM2023-10-03
03615020000236ALM800ESSILOR INTERNATIONALHLM2023-10-03
07290018993804MyRx LensScaner 6 OVER 6 VISION LTDHLM2023-08-30
72900189938040MyRx LensScaner 6 OVER 6 VISION LTDHLM2023-08-30
03664188000329VisionixLUNEAU TECHNOLOGY OPERATIONSHLM2023-06-08
03664188000541VisionixLUNEAU TECHNOLOGY OPERATIONSHLM2023-06-08
08800074500244Auto LensmeterVIEW-M TECHNOLOGY CO., LTD.HLM2023-01-10
08800074500251Auto LensmeterVIEW-M TECHNOLOGY CO., LTD.HLM2023-01-10
05070000542829AtlasEyoto, Inc.HLM2022-11-17
05070000542836AtlasEyoto, Inc.HLM2022-11-17
08034028770401TOPCONVISIA IMAGING SRLHLM2022-09-15
04562123280531PRISM COMPENSATOR for LENSMETER LM-8TOPCON CORPORATIONHLM2022-08-31
06971922131070YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21
06971922131674YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21
06971922131728YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21