Submission Details
| 510(k) Number | K895864 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 1989 |
| Decision Date | December 29, 1989 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
Cleared
Traditional
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
Dec 1989
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K895864 is an FDA 510(k) clearance for the MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP, a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II — Special Controls, product code LXS), submitted by Lasag AG (Eden Prairie, US). The FDA issued a Cleared decision on December 29, 1989, 87 days after receiving the submission on October 3, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4392.
Device Classification
| Product Code | LXS — Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4392 |
Manufacturer
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