← FDA Medical Device Classifications

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

QIT · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code
QIT
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
Review panel
OP
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
5

Source

Authoritative
FDA Device Classification database
Machine
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