Identity
- Trade Name
- Earlens Fitting Software, USB FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012). FDA UDI
- Model / Reference
- ELF002 FDA UDI
- Description
- Inductive Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012). FDA UDI
Identifiers
- Catalog Number
- ELF002 FDA UDI
- Primary DI / UDI-DI
- 00850013007295 FDA UDI
- 510(k) Number
- K182480 FDA UDI
- FDA Product Code
- PLK FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3315 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Earlens Fitting Software, USB by Earlens Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K182480 also covers:
- Earlens Contact Hearing Solution, Binaural — EARLENS CORPORATION
- Earlens Contact Hearing Solution, Monaural, Left — EARLENS CORPORATION
- Earlens Contact Hearing Solution, Monaural, Right — EARLENS CORPORATION
- Earlens Ear Tip, Binaural — EARLENS CORPORATION
- Earlens Ear Tip, Left — EARLENS CORPORATION
- Earlens Ear Tip, Right — EARLENS CORPORATION
- Earlens Fidelity Software — EARLENS CORPORATION
- Earlens Processor, Black — EARLENS CORPORATION
- Earlens Processor, Champagne — EARLENS CORPORATION
- Earlens Processor, Silver — EARLENS CORPORATION
- Earlens Tympanic Lens, Binaural — EARLENS CORPORATION
- Earlens Tympanic Lens, Left — EARLENS CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Earlens Corporation
Sources (1)
- FDA UDI a802729f-be1a-4adf-b0c0-0b081ea26485 36 fields · synced Jun 1, 2026