510(k) K023045
K023045 is an FDA 510(k) premarket notification submitted by Meridian AG for the device "MICRORUPTER V". The FDA issued a decision of Substantially Equivalent on September 26, 2002. The device falls under product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla), a Class II device regulated under 21 CFR 886.4392. Meridian AG has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2002
- Date Received
- September 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
- Device Class
- Class II
- Regulation Number
- 886.4392
- Review Panel
- OP
- Submission Type