# K220286: ELECTROCYN soma

- Pathway: 510(k) (Traditional)
- Applicant: V3Bio Sdn. Bhd
- Decided: Dec 21, 2022 after 323 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914579 (1992). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172622: Microcyn Antimicrobial Skin and Wound Cleanser, Sonoma Pharmaceuticals (2017) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional, ELECTROCYN soma is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic wounds including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin and diabetic foot ulcers. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds. ELECTROCYN soma is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Source page: https://510kreport.com/device/K220286
Methodology: https://510kreport.com/methodology