HPC · Class I · 21 CFR 886.1405

FDA Product Code HPC: Set, Lens, Trial, Ophthalmic

Leading manufacturers include Woodlyn, Inc., R.H. Burton Co. and Codman & Shurtleff, Inc..

13
Total
13
Cleared
108d
Avg days
1977
Since

FDA 510(k) Cleared Set, Lens, Trial, Ophthalmic Devices (Product Code HPC)

13 devices
1–13 of 13
Cleared Jul 19, 1995
BOBES LENS SET
K945443
Bobes S.A.
Ophthalmic · 254d
Cleared Apr 11, 1995
OTI MODEL TLS-60
K951437
Oti Medical, LLC
Ophthalmic · 15d
Cleared Jan 06, 1994
OPHTHALMIC TRIAL LENSES
K930195
Optimark Accessories and Instruments
Ophthalmic · 357d
Cleared Dec 21, 1993
CONTACT LENSES
K934859
Arno Intl., Inc.
Ophthalmic · 70d
Cleared Jul 06, 1993
MARCO TRIAL SETS
K930446
Marco Ophthalmic, Inc.
Ophthalmic · 161d
Cleared Apr 14, 1993
BURTON TRIAL LENS SET
K924786
R.H. Burton Co.
Ophthalmic · 203d
Cleared May 07, 1992
TRIAL LENS SET
K920571
R.H. Burton Co.
Ophthalmic · 90d
Cleared Feb 21, 1990
WOODLYN FULL APERTURE TRIAL LENS SET
K900478
Woodlyn, Inc.
Ophthalmic · 20d
Cleared Dec 29, 1987
CONFIRMATION TESTS
K873907
Richmond Products, Inc.
Ophthalmic · 95d
Cleared Jun 01, 1984
WOODLYN CLASSIC TRIAL LENS SET
K841766
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Mar 14, 1977
LENS SET, MENTOR TRIAL
K770389
Codman & Shurtleff, Inc.
Ophthalmic · 14d

About Product Code HPC - Regulatory Context