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/productcode/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](/device/K173371.md) | VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. | Apr 13, 2018 | SESE |
| [K172994](/device/K172994.md) | EPI K Console | Moria SA | Oct 26, 2017 | SESE |
| [K072102](/device/K072102.md) | EPIVISION SL SYSTEM | Gebauer Medizintechnik GmbH | Jan 16, 2009 | SESE |
| [K082043](/device/K082043.md) | CARRIAZO-PENDULAR MICROKERATOME | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 1, 2008 | SESE |
| [K062465](/device/K062465.md) | ZYOPTIX XP EPI SEPARATOR SYSTEM | Bausch & Lomb, Inc. | Sep 6, 2006 | SESE |
| [K052891](/device/K052891.md) | HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM | Hawken Industries | Mar 23, 2006 | SESE |
| [K051486](/device/K051486.md) | NORWOOD ABBEY CENTURION SES  EPIKERATOME | Norwood Abbey , Ltd. | Jul 6, 2005 | SESE |
| [K043183](/device/K043183.md) | EPI-K | Moria SA | Mar 25, 2005 | SESE |
| [K043150](/device/K043150.md) | AMADEUS II EPIKERATOME | Sis Ltd., Surgical Instrument Systems | Jan 31, 2005 | SESE |
| [K042083](/device/K042083.md) | MODIFICATION TO VISITOME 20-10 MICROKERATOME | Biovision AG | Nov 16, 2004 | SESE |
| [K042810](/device/K042810.md) | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | Oct 28, 2004 | SESE |
| [K041110](/device/K041110.md) | MB 105 MILLENNIUM BLADES | Millennium Biomedical, Inc. | Oct 13, 2004 | SESE |
| [K041206](/device/K041206.md) | EPITOME SYSTEM | Gebauer Medizintechnik GmbH | Sep 15, 2004 | SESE |
| [K032910](/device/K032910.md) | CARRIAZO PENDULAR | Schwind Eye-Tech-Solutions GmbH & Co. KG | Aug 30, 2004 | SESE |
| [K032836](/device/K032836.md) | M3 MICROKERATOME | Moria SA | Jun 18, 2004 | SESE |
| [K033457](/device/K033457.md) | M2 COMPATIBLE MICROKERATOME BLADE | Micro Specialties, Inc. | May 25, 2004 | SESE |
| [K033236](/device/K033236.md) | PRIZM KERATOME BLADE, MODEL MK8512M2 | Surgin Surgical Instrumentation, Inc. | Mar 26, 2004 | SESE |
| [K040204](/device/K040204.md) | ZYOPTIX XP MICROKERATOME | Bausch & Lomb, Inc. | Mar 22, 2004 | SESE |
| [K033182](/device/K033182.md) | PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD | Surgin Surgical Instrumentation, Inc. | Jan 30, 2004 | SESE |
| [K033293](/device/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/productcode/HNO](https://fda.innolitics.com/productcode/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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com