# K240248: Volnewmer™

- Pathway: 510(k) (Traditional)
- Applicant: Classys, Inc.
- Decided: Apr 29, 2024 after 90 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: 20 generations back to K943450 (1995). 119 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170758: Thermage FLX System and Accessories, Solta Medical (2017) Summary page 4.

## Most influential descendants
- K253504: Volnewmer™ (2026), 0 descendants of its own

## Indications for use
Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.

Source page: https://510kreport.com/device/K240248
Methodology: https://510kreport.com/methodology