The ACTION II Laser System is indicated for: coagulation, vaporization 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 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; 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.

AI/ML Overview

This document outlines the FDA's 510(k) clearance for the Lutronic ACTION II Laser System. The acceptance criteria and supporting study information are not applicable in the context of this FDA clearance letter, as this is a medical device and not an AI/ML powered device.

This document pertains to a medical laser system and its clearance by the FDA based on substantial equivalence to existing predicate devices. It does not involve AI/ML technology, thus the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present.

The clearance is based on non-clinical performance data and a comparison to predicate devices, which is common for traditional medical devices. No clinical performance data was required for this 510(k) submission.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Lutronic Corporation Jhung Vojir VP. Ouality And Regulatory Affairs 6 Neshaminy Interplex, Suite 100 Trevose, Pennsylvania 19053

Re: K163196

Trade/Device Name: ACTION II Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX. ONG Dated: May 12, 2016 Received: May 15, 2016

Dear Jhung Vojir:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163196

Device Name ACTION II Laser System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Lutronic ACTION II Laser System

This 510(k) Summary is being submitted in accordance with 21 CFR § 807.92.

1. Submitter's Information
Applicant:	Lutronic Corporation
	219 Sowon-roHaengsin-dong, Deogyang-guGoyang-si, Gyeonggi-do 410-220Republic of KoreaTel: (82) 31-908-3440Fax: (82) 31-907-3440
Contact Person:	Jhung Won Vojir, Ph.D.
	VP of Quality and Regulatory Affairs
	Lutronic CorporationSix Neshaminy Interplex, Suite 100Trevose, PA 19053Telephone: 215-205-2219Fax: 609-488-6958Email: jvojir@lutronic.com
Date Prepared:	May 22, 2017
2. Device Information
Trade Name:	ACTION II Laser System
Common Name:	Medical Laser System
Classification Name:	Powered Laser Surgical Instrument
Product Code:	GEX, ONG
Panel:	General and Plastic Surgery

3. Predicate Devices

510(K) Number	K153229	K150140
Company Name	Bios S.R.L.	Asclepion LaserTechnologies, GmbH

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Device Name	Superbium	MCL 31 Dermablate
Regulation Number	21 CFR 878.4810	21 CFR 878.4810
Regulation Name	Laser surgical instrument for use in general and plastic surgery and in dermatology	Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class	II	II
Product Code	GEX, ONG, ONF	GEX

4. Device Description

5. 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).

6. Substantial Equivalence

The ACTION II Laser System is substantially equivalent to the legally marketed Superbium and MCL 31 Dermablate.

Manufacturer	Lutronic Corporation	Bios S.R.L.	Asclepion LaserTechnologies, GmbH
Device Name	ACTION II Laser System	Superbium(Primary Predicate)	MCL 31 Dermablate
510(k) #	K163196	K153229	K150140
Indications for Use	The ACTION II LaserSystem is indicated for:coagulation, vaporization,ablation or cutting of soft	The 2940 nm Er:YAG LaserModule handpiece is indicatedfor: Coagulation, vaporization,ablation or cutting of soft tissue	The MCL 31 Dermablatelaser system is intended forcoagulation, vaporization,ablation or cutting of soft
	tissue (skin) in Dermatology,Plastic Surgery, OralSurgery, ENT, Gynecology,	(skin) in Dermatology, PlasticSurgery, Oral Surgery, ENT,Gynecology, General Surgery,	tissue (skin) inDermatology, PlasticSurgery, Oral Surgery,
	General Surgery, Podiatry	Podiatry and Ophthalmology	ENT, Gynecology, General
	and Ophthalmology (skin	(skin around the eyes).	Surgery, Podiatry and
	around the eyes).	Laser skin resurfacing	Ophthalmology (skin
		procedures for the treatment of:	around the eyes).
	The ACTION II Laser	• Acne scars
	Module Fractional	• Wrinkles
	Handpieces are indicated for:
	use in soft tissue (skin,	The 2940 nm Er:YAG
	cutaneous tissue,subcutaneous tissue, striated	Fractional tips are indicatedfor: use in soft tissue (skin,
	and smooth tissue, muscle,	cutaneous tissue, subcutaneous
	cartilage meniscus, mucous	tissue, striated and smooth
	membrane, lymph vessels	tissue, muscle, cartilage
	and nodes; organs, and	meniscus, mucous membrane,
	glands) such as, but not	lymph vessels and nodes;
	limited to: Dermatology and	organs, and glands) such as, but
	Plastic Surgery: skin	not limited to: Dermatology
	resurfacing treatment of	and Plastic Surgery: skin
	wrinkles; epidermal nevi;	resurfacing treatment of
	telangiectasia; spider veins;	wrinkles; epidermal nevi;
	actinic chelitis; keloids;	telangiectasia; spider veins;actinic chelitis; keloids;
	verrucae; skin tags; analtags; keratoses; scar revision	verrucae; skin tags; anal tags;
	(including acne scars).	keratoses; scar revision
		(including acne scars).
Classification	GEX 21 CFR 878.4810,	GEX 21 CFR 878.4810, ONF	GEX 21 CFR 878.4810
	ONF 21 CFR 878.4810	21 CFR 878.4810
Laser Source	Er: YAG	Er: YAG	Er: YAG
Wavelength	2940 nm	2940 nm	2940 nm
Weight of Laser	86.5 kg	35 kg	75 kg
Power max	22W	12 W	20W
Energy max	2.2 J	2.5 J	2.5 J
Pulse Width	200 – 300 µs	200-2200 µs	100-1000 µs
Spot Size	1-14 mm	1 - 9 mm	1-12 mm
Frequency max	20 Hz	5 Hz	20 Hz
Fluence max	280 J/cm² (spot 1 mm)	316 J/cm² (spot 1 mm)	318 J/cm² (spot 1 mm)

Module Fractional Handpiece
Beam Diameter (dots)	9x9	7x7, 9x9
Fluence	13 mJ/dot	13 mJ/dot
Number of Dots	81 dots/cm²	81 dots/cm² (9x9)
Max Frequency	5 Hz	5 Hz
Max Power	12 W	12 W

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7. Non-Clinical Performance Data

The ACTION II Laser System complies with the following standards: IEC 60601-1 2005 + 1 (2006) + CORR 2 (2007) + AM1 (2012) or IEC 60601-1 2012. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

IEC 60601-1-2 (Third Edition, 2007), Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility.

IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

8. Clinical Performance Data

None.

9. Conclusion

The ACTION II Laser System and the legally marketed Superbium cleared under 510(k) number K153229 have the same intended use and Indications for Use statement. Any technological differences between the ACTION II Laser System and its predicate devices are considered minor and do not raise any different types of questions regarding safety or effectiveness when used according to its intended use. The ACTION II Laser System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.