Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4370](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4370) → HNO — Keratome, Ac-Powered # HNO · Keratome, Ac-Powered _Ophthalmic · 21 CFR 886.4370 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO ## Overview - **Product Code:** HNO - **Device Name:** Keratome, Ac-Powered - **Regulation:** [21 CFR 886.4370](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4370) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) - **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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K173371.md) | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | Apr 13, 2018 | SESE | | [K172994](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K172994.md) | EPI K Console | Moria SA | Oct 26, 2017 | SESE | | [K072102](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K072102.md) | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | Jan 16, 2009 | SESE | | [K082043](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K082043.md) | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 1, 2008 | SESE | | [K062465](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K062465.md) | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | Sep 6, 2006 | SESE | | [K052891](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K052891.md) | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | Mar 23, 2006 | SESE | | [K051486](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K051486.md) | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Jul 6, 2005 | SESE | | [K043183](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K043183.md) | EPI-K | Moria SA | Mar 25, 2005 | SESE | | [K043150](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K043150.md) | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | Jan 31, 2005 | SESE | | [K042083](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K042083.md) | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | Nov 16, 2004 | SESE | | [K042810](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K042810.md) | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Oct 28, 2004 | SESE | | [K041110](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K041110.md) | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Oct 13, 2004 | SESE | | [K041206](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K041206.md) | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | Sep 15, 2004 | SESE | | [K032910](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K032910.md) | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 30, 2004 | SESE | | [K032836](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K032836.md) | M3 MICROKERATOME | Moria SA | Jun 18, 2004 | SESE | | [K033457](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K033457.md) | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | May 25, 2004 | SESE | | [K033236](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K033236.md) | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | Mar 26, 2004 | SESE | | [K040204](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K040204.md) | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | Mar 22, 2004 | SESE | | [K033182](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K033182.md) | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | Jan 30, 2004 | SESE | | [K033293](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K033293.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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