PMA N18033S112
- Device
- ACUVUE CONTACT LENS
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- PMA number
- N18033
- Supplement
- S112
- Product code
- LPM
- Decision date
- 2025-12-16
- Classification
- Ophthalmic
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- an update to the control plan for material characteristics for the Vistakon (senofilcon A) and (etafilcon A) Brand Contact Lenses
Current openFDA PMA Record#
- Device
- ACUVUE CONTACT LENS
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- PMA number
- N18033
- Supplement
- S112
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2025-12-16
- Decision code
- OK30
- Date received
- 2025-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the control plan for material characteristics for the Vistakon (senofilcon A) and (etafilcon A) Brand Contact Lenses