# K101573: Accusculpt II Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Sep 23, 2010 after 108 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: 14 generations back to K943450 (1995). 335 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082096: Powerlipo Laser System, Lutronic Corporation (2008) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.

## Most influential descendants
- K212270: DEKA LipoAI (2021), 0 descendants of its own

## Indications for use
The AccuSculpt II Laser System in 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 AccuSculpt 11 is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K101573
Methodology: https://510kreport.com/methodology