# K212270: DEKA LipoAI

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Oct 21, 2021 after 93 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 336 ancestors in all.
No later device cites it as a predicate yet.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101573: Accusculpt II Laser System, Lutronic Corporation (2010) Summary page 5.

## Indications for use
The LipoAl is indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAl is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K212270
Methodology: https://510kreport.com/methodology