Visian ICL Implantable Collamer Lens (ICL)
FDA premarket approval P030016/S037 · decided 2019-07-19
Approval details
- PMA number
- P030016
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Visian ICL Implantable Collamer Lens (ICL)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2019-04-22
- Decision date
- 2019-07-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).
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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 |