The following data is part of a premarket notification filed by Peregrine Surgical Ltd. with the FDA for Peregrine Soft Tip Aspirating Laser Probe, Model Pd720.60.
| Device ID | K061024 |
| 510k Number | K061024 |
| Device Name: | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 |
| Classification | Laser, Ophthalmic |
| Applicant | PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Contact | Todd Richmond |
| Correspondent | Todd Richmond PEREGRINE SURGICAL LTD. 51 BRITAIN DR. New Britain, PA 18901 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10632307002158 | K061024 | 000 |
| 10757770507617 | K061024 | 000 |
| 10757770507624 | K061024 | 000 |
| 10757770507631 | K061024 | 000 |
| 10632307000277 | K061024 | 000 |
| 10632307000284 | K061024 | 000 |
| 10632307000291 | K061024 | 000 |
| 10632307000307 | K061024 | 000 |
| 10632307000604 | K061024 | 000 |
| 10632307000611 | K061024 | 000 |
| 10632307000628 | K061024 | 000 |
| 10632307000635 | K061024 | 000 |
| 10632307002134 | K061024 | 000 |
| 10757770507600 | K061024 | 000 |