Submission Details
| 510(k) Number | K163632 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2016 |
| Decision Date | June 15, 2017 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Katalyst Cyclophotocoagulation Probe
Jun 2017
Decision
175d
Days
Class 2
Risk
About This 510(k) Submission
K163632 is an FDA 510(k) clearance for the Katalyst Cyclophotocoagulation Probe, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on June 15, 2017, 175 days after receiving the submission on December 22, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.
Device Classification
| Product Code | LQJ — Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4390 |
Manufacturer
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