VisuMax Femtosecond Laser
FDA 510(k) K173371 · Carl Zeiss Meditec, Inc.
510(k) numberK173371
Submission
- Device name
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
Dublin, CA, US - Received
- October 27, 2017
- Decision date
- April 13, 2018
- 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 |
|---|---|---|---|
| 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 |
| K042810 | Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 10/28/2004SE |
More from Norwood Abbey , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260694 | Zeiss Clinic 360NFJ · Traditional | 07/17/2026SE |
| K243878 | Clarus (700)QER · Traditional | 04/17/2025SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | 01/10/2025SE |
| K233911 | VISULAS combiHQF · Traditional | 09/06/2024SE |
| K240215 | Blue 400; Blue 400 SQFX · Traditional | 06/28/2024SE |
| K233933 | CIRRUS HD-OCT Model 6000OBO · Traditional | 05/17/2024SE |
| K233421 | Rescan 700OBO · Traditional | 03/08/2024SE |
| K232944 | CALLISTO eyeNFJ · Special | 12/21/2023SE |
| K232051 | VISULAS greenHQF · Traditional | 10/24/2023SE |
| K230350 | VISULAS yagHQF · Traditional | 09/22/2023SE |
Questions and answers
When was VisuMax Femtosecond Laser cleared by the FDA?
VisuMax Femtosecond Laser (K173371) received a 510(k) decision of Substantially Equivalent on April 13, 2018, 168 days after the submission was received.
What is the product code of K173371?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.