Norwood Abbey Centurion Ses Epikeratome

FDA 510(k) K051486 · Norwood Abbey , Ltd.

Substantially Equivalent

510(k) numberK051486

Submission

Device name
Norwood Abbey Centurion Ses Epikeratome
Applicant
Norwood Abbey , Ltd.
Chelsea Hgts., Victoria, AU
Received
June 6, 2005
Decision date
July 6, 2005
Decision
Substantially Equivalent (SESE)
Type
Special 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

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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
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
K042810Centurion Ses EpikeratomeHNO · Special Norwood Abbey , Ltd.10/28/2004SE

More from Norwood Abbey , Ltd.

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Questions and answers

When was Norwood Abbey Centurion Ses Epikeratome cleared by the FDA?

Norwood Abbey Centurion Ses Epikeratome (K051486) received a 510(k) decision of Substantially Equivalent on July 6, 2005, 30 days after the submission was received.

What is the product code of K051486?

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