# K172529: Vivaer ARC Stylus

- Pathway: 510(k) (Traditional)
- Applicant: Aerin Medical, Inc.
- Decided: Dec 5, 2017 after 106 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000778 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162810: InSeca ARC Stylus, Aerin Console, Aerin Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K200300: VivAer Stylus (2020), 0 descendants of its own

## Indications for use
The Vivaer ARC Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.

Source page: https://510kreport.com/device/K172529
Methodology: https://510kreport.com/methodology