The MedArt 720 Diode Laser System & Accessories is a prescription only device intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters.

The MedArt 720 Diode Laser System & Accessories is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery and ophthalmology.

The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis

Device Description

The MedArt® 720 laser unit is a Class 4 laser that emits invisible laser radiation. The unit is fed by a diode laser module providing continuous or pulsed wave laser beam operating at a wavelength of 980 nm that is primarily absorbed in melanin, haemoglobin and dark tissue. A limited amount of light is absorbed by water enabling fast increase in irradiated areas leading to effective heating of tissue at low power outputs.

AI/ML Overview

The provided text doesn't contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the MedArt® 720 Diode Laser System & Accessories, outlining its intended use, technological characteristics compared to a predicate device, and the FDA's clearance letter.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI assistance
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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K115243 Page U + U

Image /page/0/Picture/1 description: The image shows the logo for "MedArt", with the tagline "an ENERGIST - Group Company" underneath. The word "MedArt" is written in a bold, stylized font, with the letters "M", "e", and "d" appearing to have a textured or outlined effect, while the letters "A", "r", and "t" are solid black. The tagline is in a smaller, simpler font, centered below the main logo.

5. 510 (k) Summary (21 CFR 807.92)

510 (k) Submitter's Name:	MedArt A/S
Address:	MEDART A/S Industriholmen 15a Hvidovre, Denmark DK-2650
Contact Person:	Joanne Davies, Regulatory Affairs Manager, Energist Limited joanne.davies@energist-international.com
Telephone:	+44(0)1792 798768
Fax:	+44(0)1792 762099
Date:	20 th January 2010
Device Name:	MedArt® 720
Trade/Proprietary Name:	MedArt® Diode Laser System & Accessories
Classification Name:	Laser surgical instrument for use in general and plastic surgery and in dermatology
Confidentiality Preference:	No preference
Establishment Registration Number:	8021543
510 (K) Type:	Traditional
Class:	2
Panel:	General & Plastic Surgery
Product Code:	GEX
Submission Basis:	New Device
Description of Device:

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Image /page/1/Picture/1 description: The image shows the logo for MedArt, with the words "MedArt" in a stylized font. The first three letters, "Med", are in a lighter color and have a textured, almost sketched appearance, while the last three letters, "Art", are in a solid, darker color. Below the logo, in smaller font, it says "an ENERGIST * Group Company".

Intended Use:

The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis

Ear Nose, Throat &Oral Surgery	Hemostasis, incision, excision, ablation, coagulation &vaporization of tissue from the ear, nose, throat & adjacentareas including soft tissue in the oral cavity.
Dental Applications	Intraoral and extra-oral soft tissue (including marginal andinterdental gingiva and epithelial lining of free gingiva
Arthroscopy	Hemostasis, incision, excision, coagulation, vaporization andablation of joint tissues during arthroscopic surgery
Gastroenterology	Hemostasis, incision, excision, ablation, coagulation &vaporization of tissue in the upper and lowergastrointestinal tracts and also with endoscopic procedures
General surgery,Dermatology,Plastic Surgery &Podiatry	Excision, ablation, vaporization and photocoagulation ofskin lesions, hemostasis, incision, excision, vaporization,ablation and debulking of soft tissue, abdominal, rectal,skin, fat or muscle tissue and dermabrasion
Urology	Excision, vaporization, incision, coagulation, ablation andhemostasis of urological tissues
Gynecology	Ablation, excision, incision, coagulation, hemostasis andvaporization of gynecological tissue

Indications For Use:

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K110243

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Neurosurgery	Vaporization, coagulation, excision, incision ablation and hemostasis of soft tissue
Pulmonary Surgery	Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system
CardiothoraicSurgery	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue including cardiac tissues
Laser AssistedLipolysis	Laser Assisted Lipolysis
Opthalmology	The ablation, vaporization, excision, incision, and coagulation of soft tissue in opthalmology

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Predicate Device: K081015

Technological Characteristic Comparison

Characteristic	MedArt® 720	Cerelas D980	Cerelas D980
510 (k)	K110243	K081015	K081015
CFR	878.4810	878.4810	878.4810
Laser Class	4	4	4
Laser Wavelength	980 nm +/- 10 nm	980 nm	980 nm
Output Power	15W	15W	25W
Size	10.9" x 13.0" x 6.0"	7" x 9" x 14"	7" x 15" x 16"
	II	II	II
Product Code	GEX	GEX	GEX

This summary only includes information that is covered in the body of the 510 (k) .
Ths summary does not contain any unsubstantiated labeling claims o
This summary includes summary data only ●
This summary does not contain any trade secrets or confidential commercial o information
The summary does not contain any patient identifiction information �

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MedArt A/S % Energist, Ltd. Ms. Joanne Davies Clos Llyn Cwm Swansea, Wales United Kingdom SA6 8QY

JUN 2 8 2011

Re: K110243

Trade/Device Name: MedArt® 720 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 Dated: June 16, 2011 Received: June 21, 2011

Dear Ms. Davies:

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.

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Page 2 - Ms. Joanne Davies

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Ernst Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/1 description: The image shows the logo for MedArt, with the words "MedArt" in a stylized font. Below the company name, in a smaller font, it says "an ENERGIST • Group Company". The logo is simple and professional, and the text is easy to read.

Indications for Use Statement

510{k} Number (if known):

Device Name: MedArt® 720 Intended Use:

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110243

The MedArt 720 Diode Laser System & Accessories is specifically indicated for laser assisted lipolysis

Ear Nose, Throat &Oral Surgery	Hemostasis, incision, excision, ablation, coagulation &vaporization of tissue from the ear, nose, throat & adjacentareas including soft tissue in the oral cavity.
Dental Applications	Intraoral and extra-oral soft tissue (including marginal andinterdental gingiva and epithelial lining of free gingiva
Arthroscopy	Hemostasis, incision, excision, coagulation, vaporization andablation of joint tissues during arthroscopic surgery
Gastroenterology	Hemostasis, incision, excision, ablation, coagulation &vaporization of tissue in the upper and lower gastrointestinaltracts and also with endoscopic procedures
General surgery,Dermatology,Plastic Surgery &Podiatry	Excision, ablation, vaporization and photocoagulation of skinlesions, hemostasis, incision, excision, vaporization, ablationand debulking of soft tissue, abdominal, rectal, skin, fat ormuscle tissue and dermabrasion
Urology	Excision, vaporization, incision, coagulation, ablation andhemostasis of urological tissues
Gynecology	Ablation, excision, incision, coagulation, hemostasis andvaporization of gynecological tissue
Neurosurgery	Vaporization, coagulation, excision, incision ablation and

Indications for Use:

Industriholmen 15A DK-2650 Hvidovre Denmark

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K110243

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Image /page/7/Picture/2 description: The image shows the logo for MedArt, with the words "MedArt" in large, bold letters. Below the logo, in smaller letters, it says "an ENERGIST Group Company". The logo is simple and professional, and the text is clear and easy to read.

	hemostasis of soft tissue
Pulmonary Surgery	Hemostasis, vaporization, coagulation, incision, excision andablation of soft tissue in the pulmonary system
CardiothoracicSurgery	Incision, excision, vaporization, ablation, hemostasis, andcoagulation of soft tissue including cardiac tissues
Laser AssistedLipolysis	Laser Assisted Lipolysis
Opthalmology	The ablation, vaporization, excision, incision, and coagulationof soft tissue in opthalmology

Prescription Use ___X AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1/1

Neil RP Oshn for mkm

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110243

Industriholmen 15A DK-2650 Hvidovre Denmark

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.