Visian Implantable Collamer Lens (ICL)
FDA premarket approval P030016/S041 · decided 2021-07-19
Approval details
- PMA number
- P030016
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Visian Implantable Collamer Lens (ICL)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2021-06-22
- Decision date
- 2021-07-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- Adding an alternative facility for water and pre-sterile product bioburden testing.
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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 |