- Device
- Soflens 38 (polymacon) Visibility Tinted Contact Lenses
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S104
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-04-20
- Decision code
- APPR
- Date received
- 2022-01-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for removal of the Sagittal Depth measurement acceptance criteria from the finished product specifications and for minor editorial changes to finished product specification for Soflens® 38 (polymacon) Visibility Tinted Contact Lenses