ML Blade, Model ML7030
FDA 510(k) K010872 · Med-Logics, Inc.
510(k) numberK010872
Submission
- Device name
- ML Blade, Model ML7030
- Applicant
- Med-Logics, Inc.
Laguna Niguel,, CA, US - Received
- March 23, 2001
- Decision date
- June 22, 2001
- 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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| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
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More from Biovision AG
| 510(k) | Device | Decision |
|---|---|---|
| K033293 | Med-Logics, Model ML7090HNO · Traditional | 01/13/2004SE |
| K022982 | Med-Logics Microkeratome Blade, Model 7050CLBHNO · Traditional | 11/15/2002SE |
| K022716 | Med-Logics Microkeratome Blade, Model 7020CLBHNO · Traditional | 10/11/2002SE |
| 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 ML Blade, Model ML7030 cleared by the FDA?
ML Blade, Model ML7030 (K010872) received a 510(k) decision of Substantially Equivalent on June 22, 2001, 91 days after the submission was received.
What is the product code of K010872?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.