# K100098: Plasmalipo/Plasma D30 Lser Surgical Device

- Pathway: 510(k) (Traditional)
- Applicant: Jm System Co., Ltd.
- Decided: Aug 13, 2010 after 212 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The PlasmaLipo I Plasma D30 Laser Surgical Device is used for delivery of laser light to soft tissue in the contact mode during surgical procedures, including via catheters. The PlamsaLipo / Plasma 030 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, particularly for laser assisted lipolysis.

Source page: https://510kreport.com/device/K100098
Methodology: https://510kreport.com/methodology