Keratome, Ac-Powered
FDA product code HNO · Class I (low risk) · 21 CFR 886.4370 · Ophthalmic
83510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Med-Logics, Inc. 7
- Millennium Biomedical, Inc. 5
- Oasis Medical Inc 5
- Surgin Surgical Instrumentation, Inc. 4
- Bausch & Lomb, Inc. 4
- Micro Specialties, Inc. 4
- Moria SA 4
- Storz Instrument Co. 3
- Plancon Instruments 3
- Howard Instruments, Inc. 3
- Lasersight Technologies, Inc. 3
- Surgistar, Inc. 2
- Biovision, Inc. 2
- Ciba Vision Corporation 2
- Blade Works, Inc. 2
- Hawken Industries 2
- Chiron Vision Corp. 2
- Schwind Eye-Tech-Solutions GmbH & Co. KG 2
- Allergan, Inc. 2
- Gebauer Medizintechnik GmbH 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173371 | VisuMax Femtosecond LaserHNO · Traditional | Carl Zeiss Meditec, Inc. | 04/13/2018SE |
| K172994 | EPI K ConsoleHNO · Special | Moria SA | 10/26/2017SE |
| K072102 | Epivision SL SystemHNO · Traditional | Gebauer Medizintechnik GmbH | 01/16/2009SE |
| K082043 | Carriazo-Pendular MicrokeratomeHNO · Traditional | Schwind Eye-Tech-Solutions GmbH & Co. KG | 08/01/2008SE |
| K062465 | Zyoptix XP Epi Separator SystemHNO · Traditional | Bausch & Lomb, Inc. | 09/06/2006SE |
| K052891 | Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional | Hawken Industries | 03/23/2006SE |
| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
| K043150 | Amadeus II EpikeratomeHNO · Special | Sis Ltd., Surgical Instrument Systems | 01/31/2005SE |
| K042083 | Modification to Visitome 20-10 MicrokeratomeHNO · Traditional | Biovision AG | 11/16/2004SE |
| K042810 | Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 10/28/2004SE |
| K041110 | MB 105 Millennium BladesHNO · Traditional | Millennium Biomedical, Inc. | 10/13/2004SE |
| K041206 | Epitome SystemHNO · Traditional | Gebauer Medizintechnik GmbH | 09/15/2004SE |
| K032910 | Carriazo PendularHNO · Traditional | Schwind Eye-Tech-Solutions GmbH & Co. KG | 08/30/2004SE |
| K032836 | M3 MicrokeratomeHNO · Traditional | Moria SA | 06/18/2004SE |
| K033457 | M2 Compatible Microkeratome BladeHNO · Traditional | Micro Specialties, Inc. | 05/25/2004SE |
| K033236 | Prizm Keratome Blade, Model MK8512M2HNO · Traditional | Surgin Surgical Instrumentation, Inc. | 03/26/2004SE |
| K040204 | Zyoptix XP MicrokeratomeHNO · Special | Bausch & Lomb, Inc. | 03/22/2004SE |
| K033182 | Prizm Keratome Blade (B.D. Model), Model MK8530BDHNO · Traditional | Surgin Surgical Instrumentation, Inc. | 01/30/2004SE |
| K033293 | Med-Logics, Model ML7090HNO · Traditional | Med-Logics, Inc. | 01/13/2004SE |
| K032978 | Modification to Ciba Vision Centurion Ses SpikeratomeHNO · Special | Ciba Vision Corporation | 10/20/2003SE |
| K032297 | Disposable N-Pe Mickrokeratome BladesHNO · Special | Oasis Medical, Inc. | 08/26/2003SE |
| K031735 | Centurion Ses EpikeratomeHNO · Traditional | Ciba Vision Corporation | 08/21/2003SE |
| K030401 | Disposable M2-PE Microkeratome BladesHNO · Traditional | Oasis Medical, Inc. | 06/19/2003SE |
| K030891 | Surgistar Microkeratome Blade, Model No. 2400-LSKHNO · Traditional | Surgistar, Inc. | 06/17/2003SE |
| K020482 | Keratome Blade 200200 & 600600HNO · Traditional | Micro Specialties, Inc. | 12/16/2002SE |
| K022982 | Med-Logics Microkeratome Blade, Model 7050CLBHNO · Traditional | Med-Logics, Inc. | 11/15/2002SE |
| K022716 | Med-Logics Microkeratome Blade, Model 7020CLBHNO · Traditional | Med-Logics, Inc. | 10/11/2002SE |
| K022205 | Disposable N-Pe Microkeratome BladesHNO · Traditional | Oasis Medical, Inc. | 10/03/2002SE |
| K021640 | Hansatome Excellus MicrokeratomeHNO · Special | Bausch & Lomb, Inc. | 06/19/2002SE |
| K020079 | Bladeworks Microkeratome Blade, Model 7061HNO · Traditional | Blade Works, Inc. | 04/19/2002SE |
| K014000 | Vistitome 20-10 MicrokeratomeHNO · Traditional | Biovision AG | 03/11/2002SE |
| K020122 | MB 102 Millennium BladesHNO · Traditional | Millennium Biomedical, Inc. | 02/15/2002SE |
| K011833 | MB 103 Millennium BladesHNO · Traditional | Millennium Biomedical, Inc. | 02/15/2002SE |
| K013337 | Prizm Keratome Blade (Nidek Model), Model MK8514NIHNO · Traditional | Surgin, Inc. | 12/13/2001SE |
| K011195 | Prizm Blade (Moria Model) LSK / MK8510LSK; Prizm Blade (Moria Model) CB / MK8511CBHNO · Traditional | Surgin Surgical Instrumentation, Inc. | 11/06/2001SE |
| K010872 | ML Blade, Model ML7030HNO · Traditional | Med-Logics, Inc. | 06/22/2001SE |
| K010260 | Hansatome MicrokeratomeHNO · Traditional | Bausch & Lomb, Inc. | 04/27/2001SE |
| K003820 | Disposable Cb-Pe Microkeratome BladesHNO · Traditional | Oasis Medical, Inc. | 03/08/2001SE |
| K002515 | Medlogics ML 4000, Model 4000HNO · Traditional | Med-Logics, Inc. | 02/22/2001SE |
| K003143 | Millennium Blades, Model MB101HNO · Traditional | Millennium Biomedical, Inc. | 12/11/2000SE |
| K002849 | Precisionedge-Acc, Precisionedge-Acs, Precisionedge-Lsk, and Precisionedge-Cb…HNO · Traditional | Surgical Specialties Corp | 10/18/2000SE |
| K001464 | Disposable H-Pe Microkeratome BladesHNO · Traditional | Oasis | 10/02/2000SE |
| K001176 | Disposable Microkeratome Blades-PeHNO · Traditional | Oasis Medical, Inc. | 09/21/2000SE |
| K001806 | Refractive Surgery BladesHNO · Traditional | Millennium Biomedical, Inc. | 09/12/2000SE |
| K001144 | Ultraedge Keratome Blade, Model 374803 - AcsHNO · Traditional | Lasersight Technologies, Inc. | 05/05/2000SE |
| K993225 | Bladeworks Microkeratome BladeHNO · Traditional | Blade Works, Inc. | 03/20/2000SE |
| K993122 | MSP M/K BladeHNO · Traditional | Medical Sterile Products, Inc. | 03/16/2000SE |
| K994015 | Accublade (Acs Model), MK8507, Accublade (Hansotome Model), MK8508HNO · Traditional | Surgin Surgical Instrumentation, Inc. | 03/15/2000SE |
| K993190 | Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)HNO · Traditional | Surgical Instrument Systems (Sis), Ltd. | 02/10/2000SE |
| K990227 | Ultrashaper KeratomeHNO · Traditional | Lasersight Technologies, Inc. | 01/31/2000SE |
| K992978 | Ricrokeratome BladeHNO · Traditional | Surgistar, Inc. | 11/16/1999SE |
| K990900 | Microkeratome, Model MK-2000HNO · Traditional | Nidek, Inc. | 09/24/1999SE |
| K984540 | Keravision Vacuum Ring SystemHNO · Abbreviated | Keravision, Inc. | 04/28/1999SE |
| K981554 | Micratome MS7000 -Advanced Corneal/Refractive Instrumentation (Acri)HNO · Traditional | Micra Instruments , Ltd. | 12/22/1998SE |
| K980675 | Summit Krumeich-Barraquer MicrokeratomeHNO · Traditional | Summit Technology, Inc. | 12/22/1998SE |
| K983317 | Barron Microkeratome System, Model B2000HNO · Traditional | Barron Precision Instruments, LLC | 12/02/1998SE |
| K981742 | One Up Disposable Keratome HeadHNO · Traditional | Moria, Inc. | 08/25/1998SE |
| K981155 | Flapmaker Disposable MicrokeratomeHNO · Traditional | Hawken Industries | 08/14/1998SE |
| K981071 | ML MicrokeratomeHNO · Traditional | Med-Logics, Inc. | 07/23/1998SE |
| K980985 | SCMD-1000HNO · Traditional | Howard Instruments, Inc. | 05/01/1998SE |
| K980510 | Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron…HNO · Traditional | Micro Specialties, Inc. | 05/01/1998SE |
| K980508 | Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.C.M.D. Model Turokeratome…HNO · Traditional | Micro Specialties, Inc. | 05/01/1998SE |
| K974598 | Microkeratome or the MateHNO · Traditional | Howard Instruments, Inc. | 04/22/1998SE |
| K980924 | Plancon Microlamellar Keratome EvolutionHNO · Traditional | Plancon Instruments | 04/15/1998SE |
| K974004 | Automated Disposable Keratome (Adk)HNO · Traditional | Lasersight Technologies, Inc. | 01/08/1998SE |
| K972808 | Hansatome MicrokeratomeHNO · Traditional | Chiron Vision Corp. | 10/24/1997SE |
| K972727 | CBALK-1000 BladeHNO · Traditional | Howard Instruments, Inc. | 10/10/1997SE |
| K973294 | Innovatome MicrokeratomeHNO · Traditional | Innovative Optics, Inc. | 10/03/1997SE |
| K970377 | Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)HNO · Traditional | Plancon Instruments | 03/31/1997SE |
| K962661 | ML Microkeratome BladeHNO · Traditional | Med-Logics, Inc. | 12/09/1996SE |
| K960395 | Plancon Mircolamellar KeratomeHNO · Traditional | Plancon Instruments | 04/26/1996SE |
| K954058 | Barraquer-Krumeich Refractive SetHNO · Traditional | Eyetech M.V.A. | 11/06/1995SE |
| K941550 | Automatic Corneal Shaper Surgical InstrumentHNO · Traditional | Chiron Vision Corp. | 11/22/1994SE |
| K935342 | SCMD KeratomeHNO · Traditional | S.C.M.D. Keratomes of Arizona | 04/01/1994SE |
| K913697 | Automatic Corneal ShaperHNO · Traditional | Hansa Research & Development, Inc. | 11/05/1991SE |
| K911062 | Qualitative Keratometer M823 with Power SupplyHNO · Traditional | Storz Instrument Co. | 05/22/1991SE |
| K904845 | Storz Draeger Rotor KeratomeHNO · Traditional | Storz Instrument Co. | 01/22/1991SE |
| K903912 | KeratomeHNO · Traditional | Micro Precision Instrument Co. | 10/17/1990SE |
| K870807 | BKS-1000 Refractive Set Use in KeratorefractiveHNO · Traditional | Allergan, Inc. | 05/29/1987SE |
| K864065 | BKS-42 Disposable Vacuum Tubing PackHNO · Traditional | Allergan, Inc. | 12/15/1986SE |
| K860001 | Barraquer-Krumeich Refractive SetHNO · Traditional | American Medical Optics | 02/04/1986SE |
| K760726 | Electro-Keratotome, Line-OperatedHNO · Traditional | Storz Instrument Co. | 10/05/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1268-2015 Class II | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated…The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. | Med-logics Inc | 01/13/2015Terminated |
| Z-0167-2012 | Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K…The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or… | AMO Manufacturing USA, LLC | 10/12/2011Terminated |
| Z-0166-2012 | Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K…The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or… | AMO Manufacturing USA, LLC | 10/12/2011Terminated |
| Z-0165-2012 | Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K…The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or… | AMO Manufacturing USA, LLC | 10/12/2011Terminated |
| Z-2292-2011 | WaveLight FS200 Femtosecond Laser System Alcon Product Code 8065990714 WaveLight Model…The software calculating the patterns were found to has a rounding error for certain parameter ranges. These… | Wavelight AG | 04/18/2011Terminated |
| Z-0104-2009 | Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components, one…The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. | Bausch & Lomb Inc | 04/23/2008Terminated |
| Z-0103-2009 | Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is…The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. | Bausch & Lomb Inc | 04/23/2008Terminated |
| Z-1022-2007 | Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and…Reports have been received of stromal incursions after use of the product. | Bausch & Lomb Inc | 06/08/2007Terminated |
| Z-1021-2007 | Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton…Reports have been received of stromal incursions after use of the product. | Bausch & Lomb Inc | 06/08/2007Terminated |