PMA N16895S105
- Device
- SOFLENS 38(polymacon) Soft Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S105
- Product code
- LPM
- Decision date
- 2022-03-15
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Replacement of UV lamps with the same light wavelength.
Current openFDA PMA Record#
- Device
- SOFLENS 38(polymacon) Soft Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- N16895
- Supplement
- S105
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2022-03-15
- Decision code
- OK30
- Date received
- 2022-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of UV lamps with the same light wavelength.