ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
FDA premarket approval P990018/S010 · decided 2023-06-16
Approval details
- PMA number
- P990018
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Menicon Co, Ltd.
- Date received
- 2023-05-23
- Decision date
- 2023-06-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nagoya
- Statement
- Changing the manufacturing site for the lens blank material.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Miru 1day UpSide (midafilcon A) (K193399) | Menicon Co, Ltd. | 2020-06-17 |
| Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K191872) | Menicon Co, Ltd. | 2020-03-02 |
| One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (K180819) | Menicon Co, Ltd. | 2018-05-16 |
| Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (K180004) | Menicon Co, Ltd. | 2018-02-22 |
| Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136) | Menicon Co, Ltd. | 2017-11-16 |
| Menicon Saline Rinse Solution (K151768) | Menicon Co, Ltd. | 2015-08-28 |
| MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (K130805) | Menicon Co, Ltd. | 2013-07-03 |
| MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (K122273) | Menicon Co, Ltd. | 2013-01-02 |