HLX · Class II · 21 CFR 886.1630

FDA Product Code HLX: Photostimulator, Ac-powered

Leading manufacturers include Life-Tech Intl., Inc., Cadwell Laboratories, Inc. and Nicolet Biomedical Instruments.

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 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 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

About Product Code HLX - Regulatory Context