Identity
- Trade Name
- INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS FDA PMA
- Generic Name
- Implant, corneal, refractive FDA PMA
Identifiers
- PMA Number
- P980031 FDA PMA
- FDA Product Code
- LQE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Intacs Corneal Implants are refractive corneal inserts designed to modify the shape of the cornea. This device is indicated for the reduction or elimination of mild myopia, specifically for spherical equivalents ranging from -2.00 to -3.00 diopters at the spectacle plane.
These implants are intended for use in patients 21 years of age or older who demonstrate documented refractive stability of 0.50D or less over the 12 months prior to examination. The device is indicated for patients with astigmatic components of +1.00D or less. This product has received FDA PMA authorization.
Frequently asked questions
What is the primary purpose of Intacs Corneal Implants?
Intacs Corneal Implants are refractive corneal inserts used to reduce or eliminate mild myopia, specifically for patients with a spherical equivalent between -2.00 and -3.00 diopters.
Who is a candidate for this corneal implant?
Candidates must be 21 years of age or older, have documented refractive stability of 0.50D or less for at least 12 months, and have astigmatic components of +1.00D or less.
Has this device received regulatory authorization?
Yes, Intacs Corneal Implants have received FDA PMA authorization, which indicates that the device has undergone the premarket approval process required for class III medical devices.
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 | P980031 | Class III | Active |
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Manufacturer
- Manufacturer
- Addition Technology
Sources (1)
- FDA PMA P980031 23 fields · synced Sep 18, 2026