FDA.reportPublic FDA data

ALM800

Primary DI
03615020000236
Brand
ALM800
Company
ESSILOR INTERNATIONAL
Model
ALM800
Device description
This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed lens, processed framed lens and contact lens, and to put dots on them to find its axis.It also performs automatic discrimination of progressive lens, pupillary distance (PD) measurement of glass lens, UV cut percentage measurement, blue light which harmful to eyes cut percentage measurement, blue light transmittance measurement which necessary to adjust the circadian rhythm
Published
2023-10-03
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
03615020000236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03615020000236036150200002363615020000236

GMDN Terms#

Term, Definition table
TermDefinition
Automated lensmeterA 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. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
817-262-3801John.Anderson@essilorusa.com

Regulatory Flags#

DUNS number
277373213
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
03615020000397Digital C.R.PX817052026-04-09
03615020000014AKR 550AKR5502026-02-23
03615020000113CP 550CP5502026-02-23
03615020000441AKR 800AKR1JR2026-02-23
03615024000003Essilor StellestEmmetropia2025-10-16
03615024000027Essilor Stellestmyopic correction2025-10-16
03615024000034Essilor StellestMyopia+Astigmatism2025-10-16
03615020000458WAVE ANALYZER MEDICA 800WAM8002023-07-25
03615020000380WAVE ANALYZER MEDICA 700 PLUSWAM7002016-09-23
03615020000267ESSILOR RETINA 400RETINA 4002016-09-23
03615020000465ESSILOR RETINA 800RET1IN2020-04-02
03615020000489OCT500OCT2JT2020-03-23
03615020000038ALM500ALM5002023-10-03
03615020000120ALM700ALM7002023-10-03
03615020000670Vision-C 600VRS0012023-09-28
03615020000427Vision-R 800V010122023-09-11
03615020000663Vision-R 700V011122023-09-11
03615020000687Vision-S 700VS010122023-09-11
03615020000694Vision-R 800V010142023-09-11
03615020000724Vision-R 700V011142023-09-11

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
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