FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Intraocular Lens
PMA: P240038
·
Decision Sep 10, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- FINEVISION HP Trifocal IOLs
- PMA Number
- P240038
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 10, 2025
- Date Received
- October 30, 2024
- Expedited Review
- N
- Docket Number
- FDA-3951
Advisory Committee Statement
Approval for the FINEVISION HP Trifocal Intraocular Lens (IOL). The FlNEVISION HP Trifocal intraocular Lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |