The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Katalyst Revolver Laser Probes, Katalyst Revolver Illuminated Laser Probes, Katalyst Revolver Illuminated Probes.
| Device ID | K140362 |
| 510k Number | K140362 |
| Device Name: | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES |
| Classification | Laser, Ophthalmic |
| Applicant | KATALYST SURGICAL, LLC 754 Goddard Ave Chesterfield, MO 63005 |
| Contact | Meryl Koch |
| Correspondent | Meryl Koch KATALYST SURGICAL, LLC 754 Goddard Ave Chesterfield, MO 63005 |
| Product Code | HQF |
| Subsequent Product Code | HQB |
| Subsequent Product Code | MPA |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-12 |
| Decision Date | 2014-09-15 |
| Summary: | summary |