FINEVISION HP Trifocal IOLs
FDA premarket approval P240038 · decided 2025-09-10
Approval details
- PMA number
- P240038
- Trade name
- FINEVISION HP Trifocal IOLs
- Generic name
- intraocular lens
- Applicant
- Beaver Visitec International, Inc.
- Date received
- 2024-10-30
- Decision date
- 2025-09-10
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Waltham, MA
- 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 ma
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Leos Laser and Endoscopy System (K240615) | Beaver-Visitec International, Inc. | 2025-04-03 |