Microrupter V
FDA 510(k) K023045 · Meridian AG
510(k) numberK023045
Submission
- Device name
- Microrupter V
- Applicant
- Meridian AG
Thun, Bern, CH - Received
- September 12, 2002
- Decision date
- September 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4392
- Specialty
- Ophthalmic
Other 510(k)s with product code LXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901605 | Phoenix Laser Systems Ophthalmic Surgical Worksta.LXS · Traditional | Phoenix Laser Systems, Inc. | 12/13/1990SE |
| K895864 | Microruptor III Syst, Q-Switched Nd:Yag Laser CompLXS · Traditional | Lasag AG | 12/29/1989SE |
| K893987 | Nidek Model YC-1200LXS · Traditional | Nidek, Inc. | 08/18/1989SE |
| K892204 | Nidek Inc. Models YC-2000 & 3000 Ophthalmic LasersLXS · Traditional | Nidek, Inc. | 06/22/1989SE |
| K892058 | Isl QC 2000LXS · Traditional | Intelligent Surgical Lasers, Inc. | 06/15/1989SE |
More from Intelligent Surgical Lasers, Inc.
| 510(k) | Device | Decision |
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| K232417 | MR Q; MR Q Supine; MR Q SLTHQF · Traditional | 01/25/2024SE |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseHQF · Traditional | 09/12/2023SE |
| K160677 | Microruptor 6GEX · Traditional | 05/19/2017SE |
| K113390 | Laser Indirect Ophthalmoscope 500(LIO-500)GEX · Traditional | 02/14/2012SE |
| K102375 | LuciaILY · Traditional | 02/25/2011SE |
| K081962 | Lapex BCSILY · Traditional | 12/29/2008SE |
| K072823 | Merilas 532AHQF · Traditional | 12/14/2007SE |
| K034009 | Lapex 2000NHN · Abbreviated | 01/21/2005SE |
| K023238 | McpulseJOM · Traditional | 02/19/2003SE |
| K020360 | ABR-2000GZO · Traditional | 08/29/2002SE |
Questions and answers
When was Microrupter V cleared by the FDA?
Microrupter V (K023045) received a 510(k) decision of Substantially Equivalent on September 26, 2002, 14 days after the submission was received.
What is the product code of K023045?
The FDA product code is LXS – Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla, a Class II (moderate risk) device regulated under 21 CFR 886.4392.