ACTION II Laser System

Lutronic Corporation

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K163196
Device name
ACTION II Laser System
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-11-15
Decision date
2017-05-24
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

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). Laser skin resurfacing procedures for the treatment of: • Acne scars • Wrinkles

Intended 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).

Device Description

The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.

Summary parsed at:2026-06-01 05:59:16 UTC

Predicate devices

2

K163196 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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