Oneuse- Plus Microkeratome
FDA 510(k) K040297 · Moria SA
510(k) numberK040297
Submission
- Device name
- Oneuse- Plus Microkeratome
- Applicant
- Moria SA
Antony, FR - Received
- February 9, 2004
- Decision date
- March 31, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HMY – Keratome, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
Other 510(k)s with product code HMY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023092 | BD K-4000 Microkeratome SystemHMY · Special | Becton, Dickinson & CO | 10/18/2002SE |
| K022637 | BD-3000 Microkeratome System, Model K-3000 MicrokeratomeHMY · Traditional | Becton, Dickinson & CO | 10/16/2002SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | Moria SA | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | Moria, Inc. | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | Moria, Inc. | 10/12/2000SE |
| K992687 | Millenium Microkeratome, Model IMD-001HMY · Traditional | Industrial & Medical Design, Inc. | 09/24/1999SE |
| K984537 | Keratome System, Model K3000HMY · Traditional | Insight Technologies Instruments, LLC | 05/14/1999SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | Moria, Inc. | 07/24/1998SE |
| K974243 | Keratome SystemHMY · Traditional | Insight Technologies Instruments, LLC | 01/20/1998SE |
| K902857 | Visi-Drape Ophthalmic DrapesHMY · Traditional | Visitec Co. | 07/31/1990SE |
More from Visitec Co.
| 510(k) | Device | Decision |
|---|---|---|
| K172994 | EPI K ConsoleHNO · Special | 10/26/2017SE |
| K043183 | Epi-KHNO · Traditional | 03/25/2005SE |
| K032836 | M3 MicrokeratomeHNO · Traditional | 06/18/2004SE |
| K022560 | M2 Single Use MicrokertomeHMY · Traditional | 09/27/2002SE |
| K003594 | Carriazo Barraquer Single Use MicrokeratomeHMY · Traditional | 03/09/2001SE |
| K002191 | Carriazo Barraquer II MicrokeratomeHMY · Traditional | 10/12/2000SE |
| K981742 | One Up Disposable Keratome HeadHNO · Traditional | 08/25/1998SE |
| K981741 | Carriazo Barraquer MicrokeratomeHMY · Traditional | 07/24/1998SE |
Questions and answers
When was Oneuse- Plus Microkeratome cleared by the FDA?
Oneuse- Plus Microkeratome (K040297) received a 510(k) decision of Substantially Equivalent on March 31, 2004, 51 days after the submission was received.
What is the product code of K040297?
The FDA product code is HMY – Keratome, Battery-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.