510(k) K854383
K854383 is an FDA 510(k) premarket notification submitted by Carl Zeiss, Inc. for the device "KERATOLUX". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code HPL (Device, Fixation, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1290. Carl Zeiss, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1985
- Date Received
- October 30, 1985
- 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.)