The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.

Device Description

The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.

AI/ML Overview

The provided text is a 510(k) Summary for the Palomar Medical Technologies, Inc. Artisan™ Aesthetic System. It generally focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics.

Based on the information provided in the document:

Table of acceptance criteria and the reported device performance:
The document does not report specific acceptance criteria or quantitative device performance metrics from a clinical study. The submission relies on establishing substantial equivalence to predicate devices. The "Performance Data" section states: "The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device."

Without specific study results, a table of acceptance criteria and reported performance cannot be generated from this document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention any specific clinical study data (test set, sample size, or data provenance). The submission focuses on technical characteristics, intended use, and equivalence to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no specific clinical study data or test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Since no clinical study with a test set is described, no adjudication method is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document describes a light and laser system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers. Therefore, no MRMC comparative effectiveness study or related effect size for human readers improving with AI is mentioned or relevant to this submission. The device is a direct treatment system, not an AI-based analysis tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a physical light and laser system for medical procedures, not an algorithm. Therefore, the concept of "standalone algorithm-only performance" does not apply to this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As no specific clinical study results are presented, no information on the type of ground truth used is available. The substantial equivalence argument relies on the safety and effectiveness of the predicate devices.
The sample size for the training set:
Since this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in that context is not applicable or mentioned in this document.
How the ground truth for the training set was established:
As the concept of a training set is not applicable to this device type and submission, no information is provided on how ground truth for a training set was established.

In summary, the provided 510(k) Summary emphasizes substantial equivalence to predicate devices based on shared technological characteristics, mechanism of action, intended use, and physical properties. It does not contain information about specific clinical study data, acceptance criteria, or performance metrics in the format requested, as it is not a submission for a novel AI/software-driven diagnostic or therapeutic device evaluated through a performance study with explicit ground truth and sample sizes.

Summary

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11 100770

510(k) Summary

Palomar Medical Technologies, Inc.

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

1. SUBMITTER'S INFORMATION

NAME:

ﺔ ﻟﻠﺘﻘﻴﻴﻢ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﺮﺍﺗﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﺮﺍﺗﻴﺔ ﺍﻟﺘﻲ ﺗﺮﺗﻴﺐ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ

に

MAR 2 9 2010

ADDRESS: 15 Network Drive Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 418-1169

Sharon Timberlake, MSHS, RAC, CCRA CONTACT: Director of Regulatory Affairs

DATE PREPARED: January 25, 2010

2. DEVICE INFORMATION

TRADE/PROPRIETARY NAME:	Artisan ™ Aesthetic System
COMMON/USUAL NAME:	Light and Laser System
CLASSIFICATION NAME:	Laser surgical instrument for use in general andplastic surgery and in dermatology(21 CFR § 878.4810)

PRODUCT CODES: GEX, ONG

3. PREDICATE DEVICES

Palomar Medical Technologies, Inc. Lux2940 Handpiece K083900, K071768

Palomar Medical Technologies, Inc. Lux1540 Handpiece K090195. K091446

Palomar Medical Technologies, Inc. Lux1440 Handpiece K073583, K091446

Palomar Medical Technologies, Inc. Palomar StarLux Pulsed Light System K041086, K033549

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K100270

4. INTENDED ÜSE

The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

ડ. DEVICE DESCRIPTION

The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.

6. PERFORMANCE DATA

The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device.

7. SUBSTANTIAL EQUIVALENCE

The Artisan Aesthetic System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Artisan Aesthetic System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, MSHS, RAC, CCRA 15 Network Drive Burlington, Massachusetts 01803

MAR 2 9 2010

Re: K100270

Trade/Device Name: Artisan™ Aesthetic 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, ONF Dated: January 28, 2010 Received: January 29, 2010

Dear Ms. Timberlake:

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

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Page 2 - Ms. Sharon Timberlake, MSHS, RAC, CCRA

CFR Part 807); labeling (21 CFR Part 801); medical device 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,

Mark A. Milliken

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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Indications for Use

510(k) Number (if known): K 1 óć 7 7 o

Device Name: Artisan™ Aesthetic System

Indications for Use:

The Lux2940 Fractional Handpiece optics is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The Lux2940 Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

Neil R.P. Ogle for MXM
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100270

Palomar Medical Technologies, Inc. Artisan Aesthetic System

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil SP Qda for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100270

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.