# K163196: ACTION II Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: May 24, 2017 after 190 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: 18 generations back to K910422 (1992). 360 ancestors in all.
No later device cites it as a predicate yet.
0 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153229: Superbium, Bios S.R.L. (2016) Summary page 4.
- K150140: MCL 31 Dermablate, Asclepion Laser Technologies GmbH (2015) Summary page 4.

## Indications for use
The ACTION II Laser System is indicated for: coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; anal tags; keratoses; scar revision (including acne scars).

Source page: https://510kreport.com/device/K163196
Methodology: https://510kreport.com/methodology