Earlens Corp

FDA Filings

This page includes the latest FDA filings for Earlens Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010863048
FEI Number3010863048
NameEARLENS CORPORATION
Owner & OperatorEarlens Corporation
Contact Address4045-A Campbell Avenue
Menlo Park CA 94025 US
Official Correspondent
  • Simin Shamsfallah
  • x-508-8182424-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4045A CAMPBELL AVE
Menlo Park, CA 94025 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
EARLENS CORPORATION
Earlens ELF USB ELFW012023-11-03
EARLENS CORPORATION
Earlens Tympanic Lens, Right ITL01R2023-06-19
EARLENS CORPORATION
Earlens Tympanic Lens, Left ITL01L2023-06-19
EARLENS CORPORATION
Earlens Ear Tip, Right ET01R2023-06-19
EARLENS CORPORATION
Earlens Ear Tip, Left ET01L2023-06-19
EARLENS CORPORATION
Earlens Processor, Black IPR01BL2023-06-19
EARLENS CORPORATION
Earlens Processor, Silver IPR01SI2023-06-19
EARLENS CORPORATION
Earlens Processor, Champagne IPR01CH2023-06-19
EARLENS CORPORATION
Impression Dispenser IDG012023-06-19
EARLENS CORPORATION
Lateral Mixing Tip Kit IDT052021-12-13
EARLENS CORPORATION
Lateral Impression Cartridge, 6-pack IMC042021-10-14
EARLENS CORPORATION
Medial Impression Cartridge, 3-pack IMC032021-10-14
EARLENS CORPORATION
Soft Dispensing Tip (40 deg), 3 pack IDT042021-06-30
EARLENS CORPORATION
Soft Tipped Medial Mixing Tip(Blue) IDT032021-06-30
EARLENS CORPORATION
Mixing Tips for 10ml Cartirdges IDT022021-06-30
EARLENS CORPORATION
Dispensing Tips (Blue) IDT012021-06-30
EARLENS CORPORATION
Earlens Processor IPR02XX2021-06-28
EARLENS CORPORATION
Earlens Wireless Updater EWU012020-12-21
EARLENS CORPORATION
Earlens Fidelity Software, Packaged ELF0032020-10-28
EARLENS CORPORATION
Earlens Hybrid Impression Kit HIK022020-09-18
EARLENS CORPORATION
Earlens Fitting Software, USB ELF0022020-05-07
EARLENS CORPORATION
Earlens Contact Hearing Solution, Binaural IBK012020-05-07
EARLENS CORPORATION
Earlens Contact Hearing Solution Monaural, Right IK01R2020-05-07
EARLENS CORPORATION
Earlens Contact Hearing Solution, Monaural, Left IK01L2020-05-07
EARLENS CORPORATION
Earlens Tympanic Lens ITL01LR2020-05-07
EARLENS CORPORATION
Earlens Tympanic Lens ITL01X2020-05-07
EARLENS CORPORATION
Earlens Processor & Ear Tip PET01X2020-05-07
EARLENS CORPORATION
Earlens Ear Tip ET01LR2020-05-07
EARLENS CORPORATION
Earlens Ear Tip ET01X2020-05-07
EARLENS CORPORATION
Earlens Processor IPR01XX2020-05-07
EARLENS CORPORATION
Earlens Wireless Programmer WPUSB012020-05-07
EARLENS CORPORATION
Earlens Tympanic Lens TLEL1LR2020-05-07
EARLENS CORPORATION
Earlens Tympanic Lens TLEL1X2020-05-07
EARLENS CORPORATION
Earlens Processor & Light Tip PLEL1X2020-05-07
EARLENS CORPORATION
Earlens Light Tip LTEL1LR2020-05-07
EARLENS CORPORATION
Earlens Light Tip LTEL1X2020-05-07
EARLENS CORPORATION
Earlens ELF USB ELF0012020-05-07
EARLENS CORPORATION
Earlens Charger CHEL1012020-05-07
EARLENS CORPORATION
Earlens Processor PREL1XX2020-05-07
EARLENS CORPORATION
Earlens Charger CHEL1012020-02-06
EARLENS CORPORATION
Earlens Light Driven Hearing Aid, Monaural, Right MKEL1R2020-01-31
EARLENS CORPORATION
Earlens Light Driven Hearing Aid, Monaural, Left MKEL1L2020-01-31
EARLENS CORPORATION
Earlens Light Driven Hearing Aid, Binaural BKEL12020-01-31
EARLENS CORPORATION
Earlens Fitting Software, USB 2019-05-14
EARLENS CORPORATION
Earlens Contact Hearing Solution, Binaural 2019-05-14
EARLENS CORPORATION
Earlens Contact Hearing Solution Monaural, Right 2019-05-14
EARLENS CORPORATION
Earlens Contact Hearing Solution, Monaural, Left 2019-05-14
EARLENS CORPORATION
Earlens Tympanic Lens 2019-05-14
EARLENS CORPORATION
Earlens Tympanic Lens 2019-05-14
EARLENS CORPORATION
Earlens Processor & Ear Tip 2019-05-14
EARLENS CORPORATION
Earlens Ear Tip 2019-05-14
EARLENS CORPORATION
Earlens Ear Tip ET01X2019-05-14
EARLENS CORPORATION
Earlens Processor 2019-05-14
EARLENS CORPORATION
Earlens Contact Hearing Solution, Tympanic Lens, Ear Tip, Processor, Charger, Earlens Fitting Software2019-03-27
Earlens Corporation
Earlens Contact Hearing Aid2019-01-25
EARLENS CORPORATION
Hybrid Impression Kit, Impression Dispenser, Impression Cartridges (Lateral & Medial), Dispensing Tips, Mixing Tips2016-08-18
EARLENS CORPORATION
Wireless Earlens Light Driven Hearing Aid2016-04-06
EARLENS CORPORATION
Earlens Light-Driven Hearing Aid, Tympanic Lens, Light Tip, Processor, Charger, Earlens Fitting Software2015-12-28
EARLENS CORPORATION
EarLens Contact Hearing Device2015-09-29

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019012133109Yantian,China (Mainland) -> Oakland, CaliforniaRIGID BOX FOR EARLENS38 CTN
2018011631599Pusan,South Korea -> Oakland, CaliforniaINJECTION STEEL MOLD FOR PLASTIC1 CTN

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