Identity
- Trade Name
- ACUITY FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- POSTERIOR CHAMBER INTRAOCULAR LENS FDA UDI
- Model / Reference
- PL520-UV-05.0 FDA UDI
- Description
- POSTERIOR CHAMBER INTRAOCULAR LENS FDA UDI
Identifiers
- Primary DI / UDI-DI
- M454PL520UVP0501 FDA UDI
- PMA Number
- P880072 FDA UDI
- FDA Product Code
- HQL FDA UDI
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Acuity by Eyekon Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P880072 also covers:
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACUITY — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
- ACURUS — EYEKON MEDICAL, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Eyekon Medical, Inc.
Sources (1)
- FDA UDI 63988495-33ee-4658-ba0d-d09e3e9b3ce6 34 fields · synced Jun 8, 2026