VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA premarket approval P030016 · decided 2005-12-22
Approval details
- PMA number
- P030016
- Trade name
- VISIAN ICL (IMPLANTABLE COLLAMER LENS)
- Generic name
- Lens, intraocular, phakic
- Applicant
- STAAR Surgical Company
- Date received
- 2003-05-08
- Decision date
- 2005-12-22
- Days to decision
- 959 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR THE VISIAN ICL (IMPLANTABLE COLLAMER LENS) MODELS MICL12.1, MICL12.6, MICL13.2 AND MICL13.7. THE DEVICE IS INDICATED FOR ADULTS 21-45 YEARS OF AGE: 1) TO CORRECT MYOPIA RANGING FROM -3.0 DIOPTERS TO <=-15.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) TO REDUCE MYOPIA RANGING FROM GREATER THAN -15.0 DIOPTERS TO -20.0 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE; AND 3) WITH AN ANTERIOR CHAMBER DE
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510(k) clearances by this applicant
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|---|---|---|
| MicroSTAAR Injector System Cartridges (K172375) | STAAR Surgical Company | 2017-09-06 |
| MicroSTAAR Injector System Cartridges (K152357) | STAAR Surgical Company | 2015-10-30 |