Acuvue Abiliti Overnight for Myopia Management With Astigmatism
Catalogue number ACUVUE Abiliti, listed by Menicon Co., Ltd., Japan, under Lens, Contact, Orthokeratology, Overnight. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Mastervision Technology Co., Ltd. | Wuqing District | Tianjin | Manufacturer | 2 |
Record
| Listed by | Menicon Co., Ltd., Japan |
|---|---|
| FDA product code | NUU |
| Device type | Lens, Contact, Orthokeratology, Overnight |
| Device class | Class 3 |
| Regulation | 21 CFR 886.5916 |
| Establishment | Complaint-file establishment |
| Record published | 2022-01-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACUVUE Abiliti | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear | Euclid Vision Corporation | 50 |
| Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear | Euclid Vision Corporation | 8 |
| Paragon CRT | Paragon Vision Sciences, Inc. | 1 |
| Paragon Z CRT | Paragon Vision Sciences, Inc. | 1 |
| Acuvue Abiliti Overnight Therapeutic lenses for myopia management | Menicon Co., Ltd. | 1 |
| Paragon RG-4 | Paragon Vision Sciences, Inc. | 1 |
| Paragon CRT Dual Axis | Paragon Vision Sciences, Inc. | 1 |
| Paragon CRT100 | Paragon Vision Sciences, Inc. | 1 |
| Paragon Z CRT Dual Axis | Paragon Vision Sciences, Inc. | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P220015 | 2026-08-05 | DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens | Tianjin Mastervision Technology Co., Ltd. |
| P240045 | 2026-02-10 | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II | Contamac Ltd. |
| P040029 | 2024-04-15 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact | Euclid Vision Corporation |
| P990018 | 2019-11-06 | Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear | Menicon Co., Ltd. |
| P010062 | 2014-07-28 | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS | Bausch & Lomb Incorporated |
| P050031 | 2006-11-16 | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY | CooperVision, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.