Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
FDA premarket approval P090022/S037 · decided 2020-10-23
Approval details
- PMA number
- P090022
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
- Generic name
- intraocular lens
- Applicant
- Lenstec, Inc.
- Date received
- 2020-09-23
- Decision date
- 2020-10-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Petersburg, FL
- Statement
- Qualifying the addition of a prewash step to the manufacturing process for vials used to package its intraocular lenses (IOLs).
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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 |