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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prescription spectacle lenses to reduce the progression of myopia
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.
Product CodeQUR
Regulation Number 886.5845
Device Class 2


Premarket Reviews
ManufacturerDecision
ESSILOR OF AMERICA, INC.
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