Centurion Ses Epikeratome
FDA 510(k) K031735 · Ciba Vision Corporation
510(k) numberK031735
Submission
- Device name
- Centurion Ses Epikeratome
- Applicant
- Ciba Vision Corporation
Duluth, GA, US - Received
- June 4, 2003
- Decision date
- August 21, 2003
- 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 |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
| 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 |
More from Biovision AG
| 510(k) | Device | Decision |
|---|---|---|
| K133176 | Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalLPL · Traditional | 01/29/2014SE |
| K123994 | Dailies Aquacomfort Plus, Dailies Aquacomfort Plus Toric, Dailies Aquacomfort Plus…LPL · Traditional | 02/21/2013SE |
| K113168 | Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…LPL · Traditional | 03/30/2012SE |
| K083216 | Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesLPL · Special | 04/14/2009SE |
| K073459 | Ciba Vision (Lotrafilcon B) Soft Contact LensesLPL · Traditional | 02/28/2008SE |
| K072777 | Ciba Vision (Nelfilcon a) One-Day Soft Contact LensesLPL · Traditional | 01/24/2008SE |
| K062262 | Ciba Vision (Sifilcon a) Spherical, Toric, Multifocal and Multifocal Toric DesignsLPL · Traditional | 11/14/2006SE |
| K041820 | Solo-Care Aqua Antimicrobial Lens CaseLRX · Traditional | 09/09/2005SE |
| K050250 | Aquify Multipurpose SolutionLPN · Traditional | 08/10/2005SE |
| K050065 | Focus Dailies, Focus Dailies Toric and Focus Dailies ProgressivesMVN · Traditional | 05/27/2005SE |
Questions and answers
When was Centurion Ses Epikeratome cleared by the FDA?
Centurion Ses Epikeratome (K031735) received a 510(k) decision of Substantially Equivalent on August 21, 2003, 78 days after the submission was received.
What is the product code of K031735?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.