Flapmaker Disposable Microkeratome

FDA 510(k) K981155 · Hawken Industries

Substantially Equivalent

510(k) numberK981155

Submission

Device name
Flapmaker Disposable Microkeratome
Applicant
Hawken Industries
Cleveland, OH, US
Received
March 31, 1998
Decision date
August 14, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HNO – Keratome, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.4370
Specialty
Ophthalmic

Other 510(k)s with product code HNO

510(k)DeviceApplicantDecision
K173371VisuMax Femtosecond LaserHNO · Traditional Carl Zeiss Meditec, Inc.04/13/2018SE
K172994EPI K ConsoleHNO · Special Moria SA10/26/2017SE
K072102Epivision SL SystemHNO · Traditional Gebauer Medizintechnik GmbH01/16/2009SE
K082043Carriazo-Pendular MicrokeratomeHNO · Traditional Schwind Eye-Tech-Solutions GmbH & Co. KG08/01/2008SE
K062465Zyoptix XP Epi Separator SystemHNO · Traditional Bausch & Lomb, Inc.09/06/2006SE
K052891Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional Hawken Industries03/23/2006SE
K051486Norwood Abbey Centurion Ses EpikeratomeHNO · Special Norwood Abbey , Ltd.07/06/2005SE
K043183Epi-KHNO · Traditional Moria SA03/25/2005SE
K043150Amadeus II EpikeratomeHNO · Special Sis Ltd., Surgical Instrument Systems01/31/2005SE
K042083Modification to Visitome 20-10 MicrokeratomeHNO · Traditional Biovision AG11/16/2004SE

More from Biovision AG

510(k)DeviceDecision
K052891Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional 03/23/2006SE

Questions and answers

When was Flapmaker Disposable Microkeratome cleared by the FDA?

Flapmaker Disposable Microkeratome (K981155) received a 510(k) decision of Substantially Equivalent on August 14, 1998, 136 days after the submission was received.

What is the product code of K981155?

The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.