SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P090022/S004 · decided 2011-02-02
Approval details
- PMA number
- P090022
- Supplement
- S004
- 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
- 2010-12-15
- Decision date
- 2011-02-02
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- APPROVAL TO EXTEND THE POWER RANGE FOR WHICH LENSES ARE MARKETED IN 1/4 DIOPTER INCREMENT FROM 18.0 THROUGH 25.0 DIOPTERS TO 15.0 THROUGH 25.0 DIOPTERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD PS POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) 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 PLACEMENT.
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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 |