HLX · Class II · 21 CFR 886.1630

FDA Product Code HLX: Photostimulator, Ac-powered

Leading manufacturers include Life-Tech Intl., 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 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

About Product Code HLX - Regulatory Context