The following data is part of a premarket notification filed by Invuity Inc. with the FDA for Photonblade With Smoke Evacuation.
| Device ID | K191583 |
| 510k Number | K191583 |
| Device Name: | PhotonBlade With Smoke Evacuation |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Invuity Inc. 444 De Haro Street San Francisco, CA 94107 |
| Contact | Dione Fuller |
| Correspondent | Susanne Galin Invuity Inc. 444 De Haro Street San Francisco, CA 94107 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2020-03-06 |