FDA.reportPublic FDA data

Rexxam

Primary DI
04540008320152
Brand
Rexxam
Company
REXXAM CO., LTD.
Model
DL-2000 E
Catalog number
ALG02
Device description
This device intends to measure vertex powers and prismatic effects of spectacle and contact lenses, to orientate and mark uncut lenses, and to verify the correct mounting of lenses in spectacle frames.
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04540008320152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540008320152045400083201524540008320152

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.

Regulatory Flags#

DUNS number
704538487
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
04540008320138RexxamDL-2000 PALJ022026-04-20
04540008320145RexxamDL-2000 SALH022026-04-20
04540008310030RexxamNVISION-K5001RK3532025-10-17
04540008310320RexxamWAM-5500RK3632025-10-17
04540008310429RexxamDR-900DR-0532025-10-17
04540008310436RexxamACCUREF K-900RK4532025-10-17
04540008310443RexxamACCUREF R-800RE2532025-10-17
04540008310467RexxamTL-35MTL3012025-10-17
04540008310481RexxamTL-34PTL3212025-10-17
04540008310580RexxamLCD-1000PLC2062025-10-17
04540008310603RexxamRET-700RT0032025-10-17
04540008310610RexxamLCD-1000LC2042025-10-17

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
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
06971922131926YEASNChongqing Yeasn Science & Technology Co.,Ltd.HLM2022-04-21