VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA premarket approval P030016/S048 · decided 2025-11-14
Approval details
- PMA number
- P030016
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISIAN ICL (IMPLANTABLE COLLAMER LENS)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2025-02-14
- Decision date
- 2025-11-14
- Days to decision
- 273 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- approval for expanding the indicated age range from 21-45 years old to 21-60 years old for the EVO/EVO+ ICL/TICL.
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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 |