HQT · Class II · 21 CFR 886.3800

FDA Product Code HQT: Shell, Scleral

Leading manufacturers include Southwest Artificial Eyes, Inc., Mira, Inc. and Xavier A. Guerra, Ocularist, Inc..

4
Total
4
Cleared
179d
Avg days
1986
Since

FDA 510(k) Cleared Shell, Scleral Devices (Product Code HQT)

4 devices
1–4 of 4
Cleared Jul 07, 1997
SCLERAL SHELL
K970320
Xavier A. Guerra, Ocularist, Inc.
Ophthalmic · 160d
Cleared Jul 07, 1997
SCLERAL SHELL
K970327
Southwest Artificial Eyes, Inc.
Ophthalmic · 160d
Cleared Mar 31, 1986
SIMMONS SHELL
K855105
Mira, Inc.
Ophthalmic · 98d

About Product Code HQT - Regulatory Context