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FDA Product Code

FDA Product Code MUW — Clearance Directory

Device Class
Class II
Assigned Panel
Ophthalmic
21 CFR Citation
886.5916

510(k) Clearances — 6 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K183200 iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. 2019-01-09 Traditional PDF ↗
K160859 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) Contamac, Ltd. 2016-07-13 Traditional PDF ↗
K010109 FLUOROPERM 151-OK, PARAGON HDS 100-OK Paragon Vision Sciences 2001-02-28 Traditional PDF ↗
K003933 BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY Polymer Technology 2001-02-16 Traditional PDF ↗
K000224 FLUROPERM 60-OK, PARAGON HDS-OK Paragon Vision Sciences 2000-04-17 Traditional PDF ↗
K973697 AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY Airperm, Inc. 1998-04-08 Traditional PDF ↗

Product code MUW · Class II · Ophthalmic. Data: openFDA.