The following data is part of a premarket notification filed by Lasag Ag with the FDA for Microruptor Iii Syst, Q-switched Nd:yag Laser Comp.
| Device ID | K895864 |
| 510k Number | K895864 |
| Device Name: | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP |
| Classification | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | LASAG AG 6440 FLYING CLOUD DRIVE, #117 Eden Prairie, MN 55344 |
| Contact | Murray P Harris |
| Correspondent | Murray P Harris LASAG AG 6440 FLYING CLOUD DRIVE, #117 Eden Prairie, MN 55344 |
| Product Code | LXS |
| CFR Regulation Number | 886.4392 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-29 |