SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
FDA premarket approval P090022/S022 · decided 2014-06-16
Approval details
- PMA number
- P090022
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
- Generic name
- intraocular lens
- Applicant
- Lenstec, Inc.
- Date received
- 2014-05-12
- Decision date
- 2014-06-16
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- APPROVAL TO REDUCE THE SIZE OF THE SECONDARY PACKAGING WHICH HOUSES THE POUCHED INTRAOCULAR LENSES, LABEL AND DIRECTIONS FOR USE (DFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD, SOFTEC I, AND SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATON CATARACT REMOVAL INADULTS OVER THE AGE OF 21.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Lenstec LC Injection system (K161776) | Lenstec, Inc. | 2016-11-29 |
| LENSTEC LC INJECTION SYSTEM (K122848) | Lenstec, Inc. | 2013-10-18 |
| FLUID ISOLATION DEVICE (K091915) | Lenstec, Inc. | 2009-10-27 |
| LENSTEC LC INJECTION SYSTEM (K063802) | Lenstec, Inc. | 2007-05-07 |
| LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM (K060533) | Lenstec, Inc. | 2006-04-14 |
| LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES (K050638) | Lenstec, Inc. | 2005-05-31 |