# K242286: Superflow Prime Treatment System (ASP-1M)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Aimira Innovation Technology Co, Ltd.
- Decided: Nov 8, 2024 after 98 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: 8 generations back to K933002 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210693: Plexr Plus, Gmv S.R.L. (2022) Summary page 6.

## Indications for use
Superflow Prime Treatment System is used in the removal and destruction of skin lesions and coagulation of tissue.

Source page: https://510kreport.com/device/K242286
Methodology: https://510kreport.com/methodology