Modification to Visitome 20-10 Microkeratome
FDA 510(k) K042083 · Biovision AG
510(k) numberK042083
Submission
- Device name
- Modification to Visitome 20-10 Microkeratome
- Applicant
- Biovision AG
Irvine, CA, US - Received
- August 3, 2004
- Decision date
- November 16, 2004
- 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
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|---|---|---|---|
| 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 |
| K042810 | Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 10/28/2004SE |
More from Norwood Abbey , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K014000 | Vistitome 20-10 MicrokeratomeHNO · Traditional | 03/11/2002SE |
| K974392 | Leadfix Bioresorbable Membrance Pin SystemDZL · Traditional | 01/30/1998SE |
| K926251 | B-Scan Opthalmic Ultrasound Imaging SystemIYO · Traditional | 09/14/1993SE |
| K910027 | Crystal Focus Emerald Laser SLT MCX 1.5 Convex ProGEX · Traditional | 09/25/1991SE |
| K901636 | Diamond Nd:Yag Ophthalmic LaserGEX · Traditional | 06/22/1990SE |
Questions and answers
When was Modification to Visitome 20-10 Microkeratome cleared by the FDA?
Modification to Visitome 20-10 Microkeratome (K042083) received a 510(k) decision of Substantially Equivalent on November 16, 2004, 105 days after the submission was received.
What is the product code of K042083?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.