Prescription Spectacle Lenses To Reduce The Progression Of Myopia
QUR · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.5845
Classification
FDA Product Code
QUR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.5845
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by children who have myopia to reduce the rate of myopia progression. The lenses are mounted within a spectacle frame classified under § 886.5842.