The following data is part of a premarket notification filed by Meridian Ag with the FDA for Microrupter V.
| Device ID | K023045 |
| 510k Number | K023045 |
| Device Name: | MICRORUPTER V |
| Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | MERIDIAN AG BIERIGUTSTRASSE 7 Thun, Bern, CH 3608 |
| Contact | Kurt Frey |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LXS |
| CFR Regulation Number | 886.4392 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-09-12 |
| Decision Date | 2002-09-26 |
| Summary: | summary |