EPI-K
FDA 510(k) clearance K043183 · decided 2005-03-25
Clearance details
- K-number
- K043183
- Device name
- EPI-K
- Applicant
- Moria SA
- Decision
- Substantially Equivalent
- Date received
- 2004-11-17
- Decision date
- 2005-03-25
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- HNO
- Device class
- 1
- Regulation number
- 886.4370
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Antony, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VisuMax Femtosecond Laser (K173371) | Carl Zeiss Meditec, Inc. | 2018-04-13 |
| EPI K Console (K172994) | Moria SA | 2017-10-26 |
| EPIVISION SL SYSTEM (K072102) | Gebauer Medizintechnik GmbH | 2009-01-16 |
| CARRIAZO-PENDULAR MICROKERATOME (K082043) | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2008-08-01 |
| ZYOPTIX XP EPI SEPARATOR SYSTEM (K062465) | Bausch & Lomb, Inc. | 2006-09-06 |
| HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (K052891) | Hawken Industries | 2006-03-23 |
| NORWOOD ABBEY CENTURION SES EPIKERATOME (K051486) | Norwood Abbey , Ltd. | 2005-07-06 |
| AMADEUS II EPIKERATOME (K043150) | Sis Ltd., Surgical Instrument Systems | 2005-01-31 |
| MODIFICATION TO VISITOME 20-10 MICROKERATOME (K042083) | Biovision AG | 2004-11-16 |
| CENTURION SES EPIKERATOME (K042810) | Norwood Abbey , Ltd. | 2004-10-28 |
| MB 105 MILLENNIUM BLADES (K041110) | Millennium Biomedical, Inc. | 2004-10-13 |
| EPITOME SYSTEM (K041206) | Gebauer Medizintechnik GmbH | 2004-09-15 |
Recalls involving this device
No recalls on record reference this clearance.