HNO · Keratome, Ac-Powered
Ophthalmic · 21 CFR 886.4370 · Class 1
Overview
| Product Code | HNO |
|---|---|
| Device Name | Keratome, Ac-Powered |
| Regulation | 21 CFR 886.4370 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
Classification Rationale
Class I.
Recent Cleared Devices (20 of 83)
Showing 20 most recent of 83 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | Apr 13, 2018 | SESE |
| K172994 | EPI K Console | Moria SA | Oct 26, 2017 | SESE |
| K072102 | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | Jan 16, 2009 | SESE |
| K082043 | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 1, 2008 | SESE |
| K062465 | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | Sep 6, 2006 | SESE |
| K052891 | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | Mar 23, 2006 | SESE |
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Jul 6, 2005 | SESE |
| K043183 | EPI-K | Moria SA | Mar 25, 2005 | SESE |
| K043150 | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | Jan 31, 2005 | SESE |
| K042083 | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | Nov 16, 2004 | SESE |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Oct 28, 2004 | SESE |
| K041110 | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Oct 13, 2004 | SESE |
| K041206 | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | Sep 15, 2004 | SESE |
| K032910 | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 30, 2004 | SESE |
| K032836 | M3 MICROKERATOME | Moria SA | Jun 18, 2004 | SESE |
| K033457 | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | May 25, 2004 | SESE |
| K033236 | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | Mar 26, 2004 | SESE |
| K040204 | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | Mar 22, 2004 | SESE |
| K033182 | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | Jan 30, 2004 | SESE |
| K033293 | MED-LOGICS, MODEL ML7090 | Med-Logics, Inc. | Jan 13, 2004 | SESE |
Top Applicants
- Med-Logics, Inc. — 7 clearances
- Millennium Biomedical, Inc. — 5 clearances
- Oasis Medical, Inc. — 5 clearances
- Bausch & Lomb, Inc. — 4 clearances
- Micro Specialties, Inc. — 4 clearances
