510(k) K933739
K933739 is an FDA 510(k) premarket notification submitted by Varitronics for the device "360 DEGREE FIXATION LIGHT". The FDA issued a decision of Substantially Equivalent on March 14, 1994. The device falls under product code HPL (Device, Fixation, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1290.
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.)