MUW · Class II · 21 CFR 886.5916

FDA Product Code MUW: Lens, Contact (orthokeratology)

Leading manufacturers include Paragon Vision Sciences, Polymer Technology and Contamac, Ltd..

6
Total
6
Cleared
90d
Avg days
1998
Since

FDA 510(k) Cleared Lens, Contact (orthokeratology) Devices (Product Code MUW)

6 devices
1–6 of 6
Cleared Jan 09, 2019
iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
K183200
C&E GP Specialist, Inc.
Ophthalmic · 51d
Cleared Jul 13, 2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
K160859
Contamac, Ltd.
Ophthalmic · 106d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109
Paragon Vision Sciences
Ophthalmic · 47d
Cleared Feb 16, 2001
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY
K003933
Polymer Technology
Ophthalmic · 58d
Cleared Apr 17, 2000
FLUROPERM 60-OK, PARAGON HDS-OK
K000224
Paragon Vision Sciences
Ophthalmic · 84d
Cleared Apr 08, 1998
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY
K973697
Airperm, Inc.
Ophthalmic · 194d

About Product Code MUW - Regulatory Context