HLX · Class II · 21 CFR 886.1630

FDA Product Code HLX: Photostimulator, Ac-powered

Leading manufacturers include Life-Tech Intl., Inc., Electro-Diagnostic Imaging, Inc. and Cadwell Laboratories, Inc..

18
Total
18
Cleared
104d
Avg days
1979
Since

FDA 510(k) Cleared Photostimulator, Ac-powered Devices (Product Code HLX)

18 devices
1–18 of 18
Cleared May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
K003442
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 179d
Cleared Feb 03, 1999
EDI VERIS SYSTEM
K983983
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 86d
Cleared Aug 24, 1993
CLARUS ENDOSCOPIC HOOK KNIFE
K925741
Clarus Medical Systems, Inc.
Ophthalmic · 284d
Cleared Mar 02, 1992
RETINA TESTER
K914393
Retina Tester
Ophthalmic · 153d
Cleared Oct 25, 1991
SCOPTOPIC SENSITIVITY TEST-1[SST-1]
K914163
Lkc Technologies, Inc.
Ophthalmic · 38d
Cleared Feb 05, 1988
IRAS EDS INTERFEROMETRIC STIMULATOR
K873990
Randwal Instrument Co., Inc.
Ophthalmic · 127d
Cleared Nov 01, 1985
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION)
K853812
Biosan Laboratories, Inc.
Ophthalmic · 50d
Cleared Mar 12, 1984
DOWNING SPECTRAL ILLUMINATOR
K833446
Vision Health Technology
Ophthalmic · 159d
Cleared Sep 29, 1983
MILLER/NADLER GLARE TESTER
K832762
Titmus Optical, Inc.
Ophthalmic · 44d
Cleared May 16, 1983
LED GOGGLES
K831231
Cadwell Laboratories, Inc.
Ophthalmic · 31d
Cleared Apr 28, 1983
CONTRAST SENSITIVITY EQUIPMENT
K830770
Cadwell Laboratories, Inc.
Ophthalmic · 48d
Cleared Dec 28, 1982
5031 BRIGHT FLASH STIMULATOR
K822915
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5010 VISUSTIM
K822919
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5011 GANZFELD STIMULATOR
K822922
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Dec 28, 1982
5012 PARABOLIC STIMULATOR
K822923
Life-Tech Intl., Inc.
Ophthalmic · 88d
Cleared Nov 16, 1981
VTS-1000 VISUAL TESTING SYSTEM
K812331
Nicolet Biomedical Instruments
Ophthalmic · 90d
Cleared Jun 09, 1981
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
K810699
Visidyne Corp.
Ophthalmic · 85d
Cleared Aug 28, 1979
COMPUTERIZED ELECTRO-OCULOGRAPH
K790637
Potomac Medical System
Ophthalmic · 148d

About Product Code HLX - Regulatory Context