# K212329: Plasma IQ

- Pathway: 510(k) (Traditional)
- Applicant: Neauvia North America, Inc.
- Decided: Dec 9, 2021 after 135 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: 7 generations back to K933002 (1994). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192813: Plasma IQ, Neauvia North America, Inc. (2020) Summary page 4.

## Most influential descendants
- K223222: Plasma IQ (2023), 3 descendants of its own
- K241099: Plasonic (Plasonic) (2024), 2 descendants of its own
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (2026), 0 descendants of its own
- K251334: New Doublo 2.0 (2025), 0 descendants of its own
- K233760: Mjolnir Pro. (Multi–electrode plasma) (2024), 0 descendants of its own

## Indications for use
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K212329
Methodology: https://510kreport.com/methodology