Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
FDA premarket approval P990018/S008 · decided 2022-08-02
Approval details
- PMA number
- P990018
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti Overnight and ACUVUE® Abiliti Overni
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Menicon Co, Ltd.
- Date received
- 2022-02-07
- Decision date
- 2022-08-02
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nagoya
- Statement
- Approval for an expanded range of myopia treatment of up to 6.00 diopters (manifest spherical equivalent).
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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 |
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| 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 |