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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, fixation, ac-powered, ophthalmic
Regulation Description Fixation device.
Definition A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)
Product CodeHPL
Regulation Number 886.1290
Device Class 1


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1

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