Cleared Traditional

ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

K994015 · Surgin Surgical Instrumentation, Inc. · Ophthalmic
Mar 2000
Decision
110d
Days
Class 1
Risk

About This 510(k) Submission

K994015 is an FDA 510(k) clearance for the ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on March 15, 2000, 110 days after receiving the submission on November 26, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K994015 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1999
Decision Date March 15, 2000
Days to Decision 110 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

Similar Devices — HNO Keratome, Ac-powered

All 82
VisuMax Femtosecond Laser
K173371 · Carl Zeiss Meditec, Inc. · Apr 2018
EPI K Console
K172994 · Moria SA · Oct 2017
EPIVISION SL SYSTEM
K072102 · Gebauer Medizintechnik GmbH · Jan 2009
CARRIAZO-PENDULAR MICROKERATOME
K082043 · Schwind Eye-Tech-Solutions GmbH & Co. KG · Aug 2008
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · Bausch & Lomb, Inc. · Sep 2006
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K052891 · Hawken Industries · Mar 2006