The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for 23ga Curved Illuminating Laser Probe.
| Device ID | K122997 |
| 510k Number | K122997 |
| Device Name: | 23GA CURVED ILLUMINATING LASER PROBE |
| Classification | Photocoagulator And Accessories |
| Applicant | PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Contact | Ryan O'leary |
| Correspondent | Ryan O'leary PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Product Code | HQB |
| Subsequent Product Code | HQF |
| Subsequent Product Code | MPA |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-06-26 |
| Summary: | summary |