Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
FDA premarket approval P030016/S001 · decided 2018-09-13
Approval details
- PMA number
- P030016
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Visian Toric ICL (IMPLANTABLE COLLAMER LENS)
- Generic name
- Phakic toric intraocular lens
- Applicant
- STAAR Surgical Company
- Date received
- 2006-04-28
- Decision date
- 2018-09-13
- Days to decision
- 4521 days
- Decision code
- APPR
- Product code
- QCB
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval for the Visian® Toric ICL (Implantable Collamer Lens). The device is indicated for use in patients 21-45 years of age:1) for the correction of myopic astigmatism with spherical equivalent ranging from -3.0D to less than or equal to -15.0D (in the spectacle plane) with cylinder (spectacle plane) of 1.0D to 4.0D;2) for the reduction of myopic astigmatism with spherical equivalent ranging from greater than -15.0D to -20.0D (in the spectacle plane) with cylinder (spectacle plane) 1.0D to 4.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| MicroSTAAR Injector System Cartridges (K152357) | STAAR Surgical Company | 2015-10-30 |