SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P090022/S001 · decided 2010-06-17
Approval details
- PMA number
- P090022
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Lenstec, Inc.
- Date received
- 2010-05-13
- Decision date
- 2010-06-17
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE OPTIC DESIGN OF THE SOFTEC HD LENS TO INTRODUCE BI-SPHERIC OPTIC SURFACES AND CHANGES TO THE LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC I AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR BAG REPLACEMENT.
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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 |