HLXClass II
Photostimulator, Ac-powered
Ophthalmic · 21 CFR 886.1630
MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances18All time
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
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
18 clearances for this product code
- Electro-Diagnostic Imaging, Inc.May 4, 2001
K003442 · MODIFICATION TO EDI VERIS SYSTEM
- Electro-Diagnostic Imaging, Inc.Feb 3, 1999
K983983 · EDI VERIS SYSTEM
- Clarus Medical Systems, Inc.Aug 24, 1993
K925741 · CLARUS ENDOSCOPIC HOOK KNIFE
- Retina TesterMar 2, 1992
K914393 · RETINA TESTER
- Lkc Technologies, Inc.Oct 25, 1991
K914163 · SCOPTOPIC SENSITIVITY TEST-1[SST-1]
- Randwal Instrument Co., Inc.Feb 5, 1988
K873990 · IRAS EDS INTERFEROMETRIC STIMULATOR
- Biosan Laboratories, Inc.Nov 1, 1985
K853812 · PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
- Vision Health TechnologyMar 12, 1984
K833446 · DOWNING SPECTRAL ILLUMINATOR