EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
FDA premarket approval P030016/S047 · decided 2025-03-05
Approval details
- PMA number
- P030016
- Supplement
- S047
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2024-09-10
- Decision date
- 2025-03-05
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval for modification to the labeling for the EVO/EVO+ VISIAN® Implantable CollamerTM Lens for Myopia and EVO/EVO+ VISIAN® TORIC Implantable CollamerTM Lens for Myopia to reflect the findings of the P030016/S035 PMA cohort follow-up Post-approval Study.
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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 |