# K082096: Powerlipo Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Oct 8, 2008 after 76 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SmartLipo Laser System: named in the summary without a submission number
- (no number) SmartLipo Multiwavelength Laser System: named in the summary without a submission number
- (no number) Cynosure YAG MIR II Laser: named in the summary without a submission number
- (no number) CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser: named in the summary without a submission number

## Most influential descendants
- K101573: Accusculpt II Laser System (2010), 1 descendant of its own
- K212270: DEKA LipoAI (2021), 0 descendants of its own

## Indications for use
The PowerLipo 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 PowerLipo is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K082096
Methodology: https://510kreport.com/methodology