510(k) K933739

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

March 14, 1994

Date Received

August 3, 1993

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Device, Fixation, Ac-Powered, Ophthalmic

Device Class

Class I

Regulation Number

886.1290

Review Panel

OP

Submission Type

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.)