The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Katalyst Cyclophotocoagulation Probe.
| Device ID | K163632 |
| 510k Number | K163632 |
| Device Name: | Katalyst Cyclophotocoagulation Probe |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Applicant | Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 |
| Contact | Meryl Koch |
| Correspondent | Meryl Koch Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 |
| Product Code | LQJ |
| Subsequent Product Code | FFS |
| Subsequent Product Code | MPA |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817489025168 | K163632 | 000 |
| 10817489025151 | K163632 | 000 |
| 00840096211368 | K163632 | 000 |