Identity
- Trade Name
- KAMRA INLAY FDA PMA
- Generic Name
- Implant, corneal, refractive FDA PMA
Identifiers
- PMA Number
- P120023 FDA PMA
- FDA Product Code
- LQE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The KAMRA Inlay is a corneal refractive implant classified as an Implant, Corneal, Refractive under the FDA’s nomenclature. It is designed for intrastromal corneal implantation to enhance near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients.
This device is intended for single-use implantation in patients aged 45 to 60 with specific refractive criteria, including a cycloplegic spherical equivalent between +0.50 D and –0.75 D and less than or equal to 0.75 D of refractive cylinder. Supplied sterile, the KAMRA Inlay is regulated under FDA’s PMA approval (P120023) and falls under Class III device classification (Product Code: LQE).
Frequently asked questions
What is the KAMRA Inlay used for and who is the intended patient population?
The KAMRA Inlay is designed for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients. It is specifically intended for patients aged 45 to 60 who meet refractive criteria—cycloplegic spherical equivalent between +0.50 D and –0.75 D with ≤0.75 D of refractive cylinder—and do not require glasses or contacts for clear distance vision but need near correction of +1.00 D to +2.50 D.
Is the KAMRA Inlay single-use or reusable, and how is it supplied?
The KAMRA Inlay is supplied sterile and intended for single-use implantation only. It is not designed for reuse, as it is implanted directly into the cornea during surgery. The sterile packaging ensures it remains uncontaminated until use.
What are the key size or model variations available for the KAMRA Inlay?
The provided data does not specify exact size or model variations (e.g., diameter, thickness, or numerical identifiers), but the device is classified under FDA’s Product Code LQE for corneal refractive implants. For precise sizing details, refer to the manufacturer’s technical documentation or surgical planning tools, as these may include options tailored to patient-specific corneal anatomy.
How should the KAMRA Inlay be stored before use?
Since the KAMRA Inlay is supplied sterile, it must be stored according to the manufacturer’s instructions to maintain sterility. Typically, this involves keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or storage conditions before use.
What regulatory pathway does the KAMRA Inlay follow, and how was it approved?
The KAMRA Inlay follows the FDA’s Premarket Approval (PMA) pathway, classified as a Class III device under Product Code LQE. It received approval (PMA #P120023) after a review by the FDA’s Ophthalmic Devices Advisory Committee (OP), with the final decision dated April 17, 2015. This approval confirms its safety and effectiveness for the specified indication.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120023 | Class III | Active |
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Manufacturer
- Manufacturer
- CorneaGen
Sources (1)
- FDA PMA P120023 24 fields · synced Sep 18, 2026