SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
FDA premarket approval P090022/S011 · decided 2012-06-11
Approval details
- PMA number
- P090022
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
- Generic name
- intraocular lens
- Applicant
- Lenstec, Inc.
- Date received
- 2012-03-14
- Decision date
- 2012-06-11
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE OPTIC BODY SHAPE AND OVERALLDIAMETER OF YOUR SOFTEC HD LENS TO INTRODUCE A LENS WITH AN OVOID OPTIC AND OVERALL DIAMETER OF 12.50 MM AND CHANGES TO YOUR LABELING RELATED TO THE INTRODUCTION OF THE MODIFIED LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICA- TION CATARACT REMOVAL IN ADULTS OVER THE AGE OF 21. THE LENS IS INDICATED FOR CAPSULAR
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |