Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Lenstec, Inc.; 1765 Commerce Ave. N; St. Petersburg, FL 33716
• PMA Number: P090022
• Supplement Number: S039
• Date Received: 09/02/2021
• Decision Date: 09/28/2021
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Use of an alternate lens cleaner in the final cleaning process.