EVO/EVO+VISIAN Implantable Collamer Lens
FDA premarket approval P030016/S035 · decided 2022-03-25
Approval details
- PMA number
- P030016
- Supplement
- S035
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVO/EVO+VISIAN Implantable Collamer Lens
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2018-11-01
- Decision date
- 2022-03-25
- Days to decision
- 1240 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval for the EVO/EVO+ Visian Implantable Collamer Lens. The ICL is indicated for use in patients 21-45 years of age:1. for the correction of myopia with spherical equivalent ranging from -3.0D to less than or equal to-15.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;2. for the reduction of myopia with spherical equivalent ranging from greater than -15.0D to -20.0D with less than or equal to 2.5D of astigmatism at the spectacle plane;3. with an anterior chamber dept
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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 |