HPA · Class I · 21 CFR 886.1415

FDA Product Code HPA: Frame, Trial, Ophthalmic

Leading manufacturers include Ascon Medical Instruments, Ltd., Medical Equipment Designs, Inc. and Michael Onufryk.

5
Total
5
Cleared
64d
Avg days
1982
Since

FDA 510(k) Cleared Frame, Trial, Ophthalmic Devices (Product Code HPA)

5 devices
1–5 of 5
Cleared Jul 31, 1985
ATL 225 MW TRAIL LENS SET
K852548
Ascon Medical Instruments, Ltd.
Ophthalmic · 49d
Cleared Jun 05, 1985
ATF 101 TRAIL FRAME
K852126
Ascon Medical Instruments, Ltd.
Ophthalmic · 21d
Cleared Jun 01, 1984
WOODLYN LIGHTWEIGHT TRIAL FRAME
K841768
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Mar 27, 1984
IMAGE DEFLECTOR
K833669
Michael Onufryk
Ophthalmic · 161d
Cleared Jun 14, 1982
UNIVERSAL TRIAL FRAMEE
K821084
Medical Equipment Designs, Inc.
Ophthalmic · 56d

About Product Code HPA - Regulatory Context