PhotonBlade
Electrosurgical, Cutting & Coagulation & Accessories
Invuity Inc.
The following data is part of a premarket notification filed by Invuity Inc. with the FDA for Photonblade.
Pre-market Notification Details
| Device ID | K162053 |
| 510k Number | K162053 |
| Device Name: | PhotonBlade |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Invuity Inc. 444 De Haro Street San Francisco, CA 94107 |
| Contact | John Kang |
| Correspondent | John Kang 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 | 2016-07-25 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816728020523 | K162053 | 000 |
| 00816728020158 | K162053 | 000 |
Trademark Results [PhotonBlade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PHOTONBLADE 87017629 5210744 Live/Registered |
INVUITY, INC. 2016-04-28 |
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