LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P090022 · decided 2010-04-12
Approval details
- PMA number
- P090022
- Trade name
- LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Lenstec, Inc.
- Date received
- 2009-09-01
- Decision date
- 2010-04-12
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- APPROVAL FOR THE SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL). THE DEVICE 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 |