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FDA Product Code

FDA Product Code HQD — Clearance Directory

Device Class
Class II
Assigned Panel
Ophthalmic
21 CFR Citation
886.5916

510(k) Clearances — 118 records · page 2 of 2

K-Number Device Name Applicant Decision Date Clearance Type Summary
K962006 MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. 1996-10-09 Traditional PDF ↗
K962934 AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR Airperm, Inc. 1996-08-27 Traditional PDF ↗
K960584 NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY Novavision, Inc. 1996-08-15 Traditional PDF ↗
K955366 TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS Rand Scientific Corp. 1996-03-28 Traditional PDF ↗
K955900 NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR Novavision, Inc. 1996-03-25 Traditional PDF ↗
K954124 O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS Optical Polymer Research, Inc. 1996-03-19 Traditional PDF ↗
K952260 OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) Stellar Contact Lens, Inc. 1996-01-03 Traditional PDF ↗
K952165 TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS Rand Scientific Corp. 1995-06-30 Traditional PDF ↗
K945955 ROSE K LENS Rose K International , Ltd. 1995-02-07 Traditional PDF ↗
K944223 ACCUCON Innovision, Inc. 1994-12-07 Traditional PDF ↗
K941883 CONTACT LENS Airperm, Inc. 1994-10-28 Traditional PDF ↗
K943784 MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR Menicon Co, Ltd. 1994-10-20 Traditional PDF ↗
K943177 BOSTON(R) 7 - 30(ENFLUFOCON A) Polymer Technology Corp. 1994-08-25 Traditional PDF ↗
K942533 NOVALENS/NOVAWET PERCEPTION AND VANGUARD Ocutec Corporation, Inc. 1994-08-05 Traditional PDF ↗
K942365 BOSTON VII Polymer Technology Corp. 1994-06-23 Traditional PDF ↗
K940277 PAFLUFOCON A, B, C & D Paragon Vision Sciences 1994-05-09 Traditional PDF ↗
K841163 CONTACT LENS INSERTER/REMOVER Optimum Manufacturers, Inc. 1984-06-01 Traditional PDF ↗
K840115 SWISS OPTICAL PRODUCTS-CONTACT CASE Moonbeam International, Inc. 1984-06-01 Traditional PDF ↗

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