FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
PMA: P180035
·
Supplement: S012
·
Decision Dec 7, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
- Trade Name
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- PMA Number
- P180035
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- QIT
- Generic Name
- Daily wear soft contact lens to reduce the progression of myopia
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 7, 2022
- Date Received
- September 30, 2022
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the post-approval study (PAS) protocol.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIT | Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | FDA class 3 | Unknown |