Automated Disposable Keratome (Adk)

FDA 510(k) K974004 · Lasersight Technologies, Inc.

Substantially Equivalent

510(k) numberK974004

Submission

Device name
Automated Disposable Keratome (Adk)
Applicant
Lasersight Technologies, Inc.
Orlando, FL, US
Received
October 21, 1997
Decision date
January 8, 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

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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
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
K001144Ultraedge Keratome Blade, Model 374803 - AcsHNO · Traditional 05/05/2000SE
K990227Ultrashaper KeratomeHNO · Traditional 01/31/2000SE

Questions and answers

When was Automated Disposable Keratome (Adk) cleared by the FDA?

Automated Disposable Keratome (Adk) (K974004) received a 510(k) decision of Substantially Equivalent on January 8, 1998, 79 days after the submission was received.

What is the product code of K974004?

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