Device, Fixation, Ac-powered, Ophthalmic
Ophthalmic · 21 CFR 886.1290
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.)
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Wavelight Gmbh
Teltow Brandenburg, DE
S.a. Instrumentation Difra
Eupen Liege, BE
Rmf Design And Manufacturing Inc.
Mississauga Ontario, CA
Novex Innovations, Llc
Winston Salem, NC, US
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Good-lite Co.
ELGIN, IL, US
Sterigenics U.s., Llc
Haw River, NC, US
Gulden Ophthalmics
Elkins Park, PA, US
Medneuroptek Inc.
Johns Creek, GA, US
510(k) clearances
7 clearances for this product code
- Storz Instrument Co.Aug 29, 1994
K931731 · STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY
- VaritronicsMar 14, 1994
K933739 · 360 DEGREE FIXATION LIGHT
- Richmond Products, Inc.Dec 11, 1987
K873914 · ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)
- Carl Zeiss, Inc.Nov 12, 1985
K854383 · KERATOLUX
- Fite Engineering Corp.Jul 28, 1980
K801381 · FITE FIXATION TOY FOR OCULAR EXAM
- Life-Tech Instruments, Inc.Mar 10, 1980
K800112 · AMBLYOPIA TRAINER
- Clement Clarke, Inc.Jan 26, 1979
K781313 · VISION-STIMULATOR, CAM