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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device digital prismatic correction
Regulation Description Ophthalmic Fresnel prism.
Definition The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction.
Product CodeSCW
Regulation Number 886.1655
Device Class 1


Premarket Reviews
ManufacturerDecision
APPLE, INC.
  SUBSTANTIALLY EQUIVALENT 2

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