FDA.reportPublic FDA data

Earlens Fitting Software, USB

Primary DI
00850013007295
Brand
Earlens Fitting Software, USB
Company
EARLENS CORPORATION
Model
ELF002
Catalog number
ELF002
Device description
Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
Published
2019-05-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PLKTympanic Membrane Direct Contact Hearing Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLKTympanic Membrane Direct Contact Hearing AidEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182480000Earlens Contact Hearing AidEarlens Corporation2019-01-25PLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013007295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013007295008500130072958500130072950850013007295

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
611658795
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500130070192Earlens ELF USBELFW01ELFW012016-09-24
00850013007417Earlens Fidelity SoftwareELF003ELF0032020-10-20
00850013007042Earlens ELF USBELF001ELF0012016-09-24
00850013007387Impression DispenserIDG01IDG012023-06-09
00850013007516Earlens Processor, Champagne IPR01CHIPR01CH2023-06-09
00850013007523Earlens Processor, SilverIPR01SIIPR01SI2023-06-09
00850013007530Earlens Processor, BlackIPR01BLIPR01BL2023-06-09
00850013007547Earlens Ear Tip, LeftET01LET01L2023-06-09
00850013007554Earlens Ear Tip, RightET01RET01R2023-06-09
00850013007561Earlens Tympanic Lens, LeftITL01LITL01L2023-06-09
00850013007578Earlens Tympanic Lens, RightITL01RITL01R2023-06-09
00850013007370Medial Impression CartridgesIMC03IMC032021-10-06
00850013007479Soft Medial Mixing TipsIDT04IDT042021-06-22
00850013007509Lateral Mixing TipsIDT05IDT052021-12-03
00850013007493Lateral Impression CartridgesIMC04IMC042021-10-06
00850013007349Earlens Hybrid Impression KitHIK02HIK022020-09-10
00850013007110Earlens Wireless ProgrammerWPUSB01WPUSB012016-09-24
00850013007202Earlens ProcessorIPR01XXIPR01XX2019-05-06
00850013007219Earlens Ear TipET01XET01X2019-05-06
00850013007226Earlens Ear Tip, BinauralET01LRET01LR2019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503535519Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535526Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535533Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535540Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535516MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535523MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535530MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
16932503535547MTMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535557Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
06932503535564Disposable Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd.PLK2023-06-28
00850013007516Earlens Processor, Champagne EARLENS CORPORATIONPLK2023-06-09
00850013007523Earlens Processor, SilverEARLENS CORPORATIONPLK2023-06-09
00850013007530Earlens Processor, BlackEARLENS CORPORATIONPLK2023-06-09
00850013007547Earlens Ear Tip, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007554Earlens Ear Tip, RightEARLENS CORPORATIONPLK2023-06-09
00850013007561Earlens Tympanic Lens, LeftEARLENS CORPORATIONPLK2023-06-09
00850013007578Earlens Tympanic Lens, RightEARLENS CORPORATIONPLK2023-06-09
00850013007462Earlens ProcessorEARLENS CORPORATIONPLK2021-06-18
00850013007417Earlens Fidelity SoftwareEARLENS CORPORATIONPLK2020-10-20
00850013007202Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
00850013007219Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007226Earlens Ear Tip, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007233Earlens Processor & Ear TipEARLENS CORPORATIONPLK2019-05-06
00850013007240Earlens Tympanic LensEARLENS CORPORATIONPLK2019-05-06
00850013007257Earlens Tympanic Lens, BinauralEARLENS CORPORATIONPLK2019-05-06
00850013007264Earlens Contact Hearing Solution, Monaural, LeftEARLENS CORPORATIONPLK2019-05-06
00850013007271Earlens Contact Hearing Solution, Monaural, RightEARLENS CORPORATIONPLK2019-05-06
00850013007288Earlens Contact Hearing Solution, BinauralEARLENS CORPORATIONPLK2019-05-06
08500130070208Earlens ProcessorEARLENS CORPORATIONPLK2019-05-06
08500130070215Earlens Ear TipEARLENS CORPORATIONPLK2019-05-06