The following data is part of a premarket notification filed by Aerin Medical, Inc. with the FDA for Vivaer Arc Stylus.
| Device ID | K172529 |
| 510k Number | K172529 |
| Device Name: | Vivaer ARC Stylus |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Aerin Medical, Inc. 232 E. Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Shannon Scott |
| Correspondent | Shannon Scott Aerin Medical, Inc. 232 E. Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28886479300157 | K172529 | 000 |
| 08886479300146 | K172529 | 000 |