Panels › Ophthalmic › Product code HQD · Class 2
Lens, Contact (Other Material) - Daily
Regulation 886.5916
1510(k)s in 12 months (118 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in HQD
| Company | 510(k)s | Recalls |
|---|---|---|
| Acuity Polymers, Inc. | 11 | 0 |
| Contamac, Ltd. | 11 | 0 |
| Paragon Vision Sciences | 11 | 0 |
| Synergeyes | 11 | 0 |
| Bausch & Lomb, Inc. | 8 | 1 |
| Polymer Technology | 8 | 0 |
| Menicon Co, Ltd. | 7 | 0 |
| Boston Foundation For Sight | 1 | 2 |
| Innovision, Inc. | 3 | 0 |
| The Lagado Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2008 | K073184 | BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS Bausch & Lomb, Inc. | HQD |
| Aug 15, 2007 | K071266 | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Inc. | HQD |
| Aug 2, 2007 | K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES Bausch & Lomb, Inc. | HQD |
| May 1, 2007 | K070637 | FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES Paragon Vision Sciences | HQD |
| May 1, 2007 | K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. Contamac, Ltd. | HQD |
| Nov 1, 2006 | K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| Jun 22, 2006 | K061120 | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES Synergeyes, Inc. | HQD |
| Mar 15, 2006 | K060102 | SYNERGEYES PS HYBRID CONTACT LENS Synergeyes, Inc. | HQD |
| Feb 10, 2006 | K052983 | FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES Paragon Vision Sciences | HQD |
| Jan 30, 2006 | K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES Bausch & Lomb, Incorporated | HQD |
| Nov 30, 2005 | K052675 | SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS Synergeyes | HQD |
| Nov 2, 2005 | K052507 | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR The Lagado Corp. | HQD |
| Sep 2, 2005 | K051035 | SYNERGEYES (PAFLUCON D HEM-IBERFILCON A) HYBRID CONTACT LENS Synergeyes | HQD |
| Sep 16, 2004 | K033599 | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS The Lagado Corp. | HQD |
| Mar 19, 2004 | K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| Feb 12, 2003 | K024164 | COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT Metro Optics, Inc. | HQD |
| Oct 11, 2002 | K021752 | FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL Lucid Korea Co., Ltd., KR | HQD |
| Sep 12, 2002 | K021977 | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR Contamac, Ltd. | HQD |
| Aug 22, 2002 | K022128 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Incorporated | HQD |
| May 30, 2002 | K013646 | ROSE K POST GRAFT LENS Rose K International , Ltd., NZ | HQD |
| Apr 25, 2002 | K013310 | PVS BASIC 2; EPIC 2 Paragon Vision Sciences | HQD |
| Apr 3, 2002 | K013762 | RIGID GAS PERMEABLE CONTACT LENS Bausch & Lomb, Incorporated | HQD |
| Mar 29, 2002 | K020006 | DYNA INTRA-LIMBAL LENS Lens Dynamics, Inc. | HQD |
| Sep 12, 2001 | K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION Polymer Technology Corp. | HQD |
| Aug 1, 2001 | K010454 | THE ALBERTA LENS SM2, SULFOCON B Progressive Optical Research , Ltd., CA | HQD |
| Jul 27, 2001 | K011914 | HYDRO2, HS-75 Innovision, Inc. | HQD |
| Feb 16, 2001 | K003932 | BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY Polymer Technology | HQD |
| Dec 8, 2000 | K002845 | PAFLUFOCON C AND E DAILY CONTACT LENS Paragon Vision Sciences | HQD |
| Nov 21, 2000 | K002703 | O-PERM 30 Optical Polymer Research, Inc. | HQD |
| Oct 31, 2000 | K002025 | RIGID GAS PERMEABLE CONTACT LENS Polymer Technology | HQD |
| Aug 28, 2000 | K001960 | RIGID GAS PERMEABLE CONTACT LENS Polymer Technology | HQD |
| May 26, 2000 | K000795 | RIGID GAS PERMEABLE CONTACT LENS Polymer Technology | HQD |
| May 22, 2000 | K993586 | SPORTSIGHT GP Paragon Vision Sciences | HQD |
| May 19, 2000 | K000233 | MENICON SF-P Menicon Co, Ltd. | HQD |
| May 19, 2000 | K000133 | MENICON Z Menicon U.S.A., Inc. | HQD |
| May 12, 2000 | K000485 | HYDRO2, HS-75 Innovision, Inc. | HQD |
| Feb 2, 2000 | K992787 | EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR Specialty Ultravision, Inc. | HQD |
| Jun 29, 1999 | K991781 | FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS G.T. Laboratories, Inc. | HQD |
| Jun 29, 1999 | K991780 | FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C G.T. Laboratories, Inc. | HQD |
| Apr 21, 1999 | K984436 | PVS BASICS Paragon Vision Sciences | HQD |
| Apr 14, 1999 | K990895 | OXYCON LENS Concise Contact Lens Co. | HQD |
| Mar 31, 1999 | K990264 | COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS Metro Optics of Austin, Inc. | HQD |
| Aug 4, 1998 | K980197 | ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR Specialty Ultravision, Inc. | HQD |
| May 11, 1998 | K980741 | BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) Polymer Technology Div. Wilmington Partners, L.P. | HQD |
| Mar 30, 1998 | K974636 | FLOSI RIGID GAS PERMEABLE CONTACT LENS Futuristic Design Assoc. | HQD |
| Aug 22, 1997 | K972443 | MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS Menicon U.S.A., Inc. | HQD |
| Jul 31, 1997 | K963744 | BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) Benz Research and Development Corp. | HQD |
| Jul 31, 1997 | K963512 | BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL Benz Research and Development Corp. | HQD |
| May 6, 1997 | K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS Polymer Technology Corp. | HQD |
| Nov 20, 1996 | K963010 | LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENS FOR DAILY WEAR Permeable Technologies, Inc. | HQD |
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