Epi-K
FDA 510(k) K043183 · Moria SA
510(k) numberK043183
Submission
- Device name
- Epi-K
- Applicant
- Moria SA
Antony, FR - Received
- November 17, 2004
- Decision date
- March 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K043150 | Amadeus II EpikeratomeHNO · Special | Sis Ltd., Surgical Instrument Systems | 01/31/2005SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K172994 | EPI K ConsoleHNO · Special | 10/26/2017SE |
| K032836 | M3 MicrokeratomeHNO · Traditional | 06/18/2004SE |
| K040297 | Oneuse- Plus MicrokeratomeHMY · Traditional | 03/31/2004SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | 10/12/2000SE |
| K981742 | One Up Disposable Keratome HeadHNO · Traditional | 08/25/1998SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | 07/24/1998SE |
Questions and answers
When was Epi-K cleared by the FDA?
Epi-K (K043183) received a 510(k) decision of Substantially Equivalent on March 25, 2005, 128 days after the submission was received.
What is the product code of K043183?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.