Amadeus II Epikeratome
FDA 510(k) K043150 · Sis Ltd., Surgical Instrument Systems
510(k) numberK043150
Submission
- Device name
- Amadeus II Epikeratome
- Applicant
- Sis Ltd., Surgical Instrument Systems
Littleton, CO, US - Received
- November 15, 2004
- Decision date
- January 31, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K173371 | VisuMax Femtosecond LaserHNO · Traditional | Carl Zeiss Meditec, Inc. | 04/13/2018SE |
| K172994 | EPI K ConsoleHNO · Special | Moria SA | 10/26/2017SE |
| K072102 | Epivision SL SystemHNO · Traditional | Gebauer Medizintechnik GmbH | 01/16/2009SE |
| K082043 | Carriazo-Pendular MicrokeratomeHNO · Traditional | Schwind Eye-Tech-Solutions GmbH & Co. KG | 08/01/2008SE |
| K062465 | Zyoptix XP Epi Separator SystemHNO · Traditional | Bausch & Lomb, Inc. | 09/06/2006SE |
| K052891 | Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional | Hawken Industries | 03/23/2006SE |
| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
| K042083 | Modification to Visitome 20-10 MicrokeratomeHNO · Traditional | Biovision AG | 11/16/2004SE |
| K042810 | Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 10/28/2004SE |
More from Norwood Abbey , Ltd.
Questions and answers
When was Amadeus II Epikeratome cleared by the FDA?
Amadeus II Epikeratome (K043150) received a 510(k) decision of Substantially Equivalent on January 31, 2005, 77 days after the submission was received.
What is the product code of K043150?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.