Med-Logics Microkeratome Blade, Model 7050CLB
FDA 510(k) K022982 · Med-Logics, Inc.
510(k) numberK022982
Submission
- Device name
- Med-Logics Microkeratome Blade, Model 7050CLB
- Applicant
- Med-Logics, Inc.
Laguna Hills, CA, US - Received
- September 9, 2002
- Decision date
- November 15, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HNO – Keratome, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
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| 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 |
|---|---|---|
| K033293 | Med-Logics, Model ML7090HNO · Traditional | 01/13/2004SE |
| K022716 | Med-Logics Microkeratome Blade, Model 7020CLBHNO · Traditional | 10/11/2002SE |
| K010872 | ML Blade, Model ML7030HNO · Traditional | 06/22/2001SE |
| K010353 | Med-Logics Disposable Alk TubingKYG · Traditional | 04/27/2001SE |
| K002515 | Medlogics ML 4000, Model 4000HNO · Traditional | 02/22/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | 08/18/2000SE |
| K983448 | ML Universal TubingMSR · Traditional | 12/18/1998SE |
| K981071 | ML MicrokeratomeHNO · Traditional | 07/23/1998SE |
| K972522 | Ml-Disposable PakMSR · Traditional | 09/30/1997SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | 05/22/1997SE |
Questions and answers
When was Med-Logics Microkeratome Blade, Model 7050CLB cleared by the FDA?
Med-Logics Microkeratome Blade, Model 7050CLB (K022982) received a 510(k) decision of Substantially Equivalent on November 15, 2002, 67 days after the submission was received.
What is the product code of K022982?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.