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
- DS555-UV-13.5 FDA UDI
- Description
- POSTERIOR CHAMBER INTRAOCULAR LENS FDA UDI
Identifiers
- Primary DI / UDI-DI
- M454DS555UVP1351 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Posterior-chamber intraocular lens, pseudophakic
ACUITY is a high-quality, implantable intraocular lens designed for permanent replacement of the natural lens in patients with cataracts. Featuring a synthetic material and a sterile injector, this device offers unparalleled precision and comfort. Our expert team has meticulously crafted ACUITY to provide optimal vision and long-term durability.
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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
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 3af8c46d-5310-42d9-ac29-cf363409d264 34 fields · synced Jul 27, 2026