Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
The Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia is a contact lens intended for children with myopia both to reduce the rate of progression of myopia and to optically correct myopic refractive error. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA), reviewed by the Ophthalmic panel, with no regulation number assigned. The product code is QIT. The device is not flagged as an implant or life-sustaining device, though it requires the highest level of regulatory scrutiny due to its novel therapeutic claim of slowing myopia progression in children.
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Basic Information
- Product Code
- QIT
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OP
- Submission Type
- 2
Device Characteristics
Definition
Intended to be worn on the surface of the eye in children who have myopia to: Reduce the rate of progression of myopia, and Optically correct myopic refractive error.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.