SPECIAL 510(K): PALOMAR ICON AESTHETIC SYSTEM

Posting of FDA 510(k) Approval Documents that are part of the public record on the FDA's Website. You can go to this link and review 510(k) appoval summaries for all medical devices going back to 1999:

http://www.fda.gov/MedicalDevices/Produ ... 242632.htm

SPECIAL 510(K): PALOMAR ICON AESTHETIC SYSTEM

PostPosted by DCNGA » Sun Oct 02, 2011 8:02 pm

MAR 1 7 20DH
510(k) Summary
This 5 1 0(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
NAME: Palomar Medical Technologies, Inc.
ADDRESS: 15 Network Drive
Burlington, MA 01803
Phone: (781) 993-2300
Fax: (781) 418-1169
CONTACT: Sharon Timberlake, MSHS, RAC, CCRA
Director of Regulatory Affairs
DATE PREPARED: February 24, 2011
2. DEVICE INFORMATION
TRADE/PROPRIETARY NAME: Palomar IconTM Aesthetic System
COMMON/UISUAL NAME: Light and Laser System
CLASSIFICATION NAME: Laser surgical instrument for use in general and
plastic surgery and in dermatology
(21 CFR § 878.4810)
PRODUCT CODES: GEX, ONG

3. PREDICATE DEVICES

Palomar Medical Technologies, Inc.
Artisan System (Luxl1540, Luxl1440, Lux2940, MaxO)
K 100270
Palomar Medical Technologies, Inc.
Combination Fractional Treatment
(Luxl54O, Luxl44O, Lux2940)
K 101506
Palomar Medical Technologies, Inc.
LuxlO64 Handpiece
K04 1879
Palomar Medical Technologies, Inc.
LuxIR Handpiece
K070298
PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 1 OF 3
PALOMAR ICON AESTHETIC SYSTEM
Palomar Medical Technologies, Inc.
Palomar StarLux System
Intense Pulsed Light Handpieces
K041086, K033549

4. INTENDED USE

The 2940 Ablative Laser 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 tumnors, debulking cysts and superficial skin lesions.

The .2940 Fractional Ablative Laser 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 1540 Fractional Non-ablative Laser H-andpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acnescars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The 1440 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural
irregularities, dyschromia and pigmented lesions. The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic
applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary
increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 2 OF 3
PALOMAR ICON AESTHETIC SYSTEM

The 1064 Laser 1-andpiece is intended for the removal of unwanted hair for skin types IVI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacca, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from
skin types 1-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

5. DEVICE DESCRIPTION

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

6. PERFORMANCE DATA

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

7. SUBSTANTIAL EQUIVALENCE

The Palomar Icon 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 5 10(k) Premarket Notification which demonstrates that the Palomar Icon Aesthetic
System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.

PALOMAR MEDICAL TECHNOLOGIES, INC. PAGE 3 OF3
PALOMAR ICON AESTHETIC SYSTEM
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
rood aid Drug AdministratiOnl
10903 New Hampshire ANvnue
Documenit Control Room -\V066-G609
Silver Spring, NID 20993-0002
Palomnar Medical Technologies, Inc.
%/ Sharon Timberlake, MSFIS, PAC, CCR A
Director of Regulatory AffairsMA 7zm
15 Network DriveMA 17
Burlington, Massachusetts 0 1803

Re: K103664

Trade/Device Name: Paloihar Icon T"Aesthetic System
Regulation Number: 21 CER 878.48 10
Regulation Maine: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II
Product Code: ONG, GEX

Dated: February 24, 2011

Received: February 25, 2011

Dear Ms. Tinmberlake:

We have reviewed your Section 5 10(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: CDRI-I 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 Reister.
Page 2 - Sharon Timberlake, MSHIS, PAC, CCRA.

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 CER Part 801); medical device reporting (reporting of medical device-related adverse events) (2 1 CER 803 ); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2 1 CER Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 JFR 1000-1050.

If You desire specific advice for your device on our labeling regulation (21 CER Part 80 1), please go to http)//wwav.fda.gov/AboutFDA/CentersOffices/CDRF/CDIZI-10ffICeS/LICil II 5809.htmn for the Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21ICFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 JFR Part 803), please go to littp://www.fda.gov/MedicalDevices/Safe ... defaulthtm for the CDR-I'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) 63 8-2041 or (301) 7-96-7100 or at its Internet address

hittp)://wvww.lfda.-,ov/MedicalDevices/ResouircesforYoui/Industry/defluithtlln

Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
And Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
5 10(k) Number (if known): 0 0 3 4 q
Device Name: Palomar IconTM Aesthetic System

Indications for Use:
The 2940 Ablative Laser 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 2940 Ablative Laser 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 1540 Fractional Non-ablative Laser 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 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities,
7y,2 dyschromia and pigmented lesions.

e1440 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities,
Z = g schromia and pigmented lesions.

C0-r* 1Fc e IR Handpiece is intended for photocoagulation of soft tissue in dermatologic p lications. In addition, it is intended to provide topical heating for the purpose of elevating sue temperature for the temporary relief of minor muscle and joint pain and stiffness, the
0. te nporary relief of minor joint pain associated with arthritis, the temporary increase in local Sci culation where applied, and the relaxation of muscles. In addition, it may also help muscle V,5 s isins, minor sprains and strains, and minor muscular back pain.

GC F Page I of 2

PALOMAR MEDICAL TECHNOLOGIES, INC. CONFIDENTIAL

SPECIAL 5 10(K): PALOMAR ICON TM AESTHETIC SYSTEM

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots),
pigmented seborrheic keratoses, nevi, chloasma, eafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbac (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin
types 1-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias,
rosacea, facial and leg veins.

Prescription Use X AN/R Over-The-Counter Use ___
(Pant 21 CFR 801 Subpart D) AN/R (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sig -off Division of Surgical, Orthopedic, and Restomative Devices
5I10ON)Numbr q_____
Page 2 of 2
PALOMAR MEDICAL TECHNOLOGIES, INC. CONFIDENTIAL
SPECIAL 5 10(K): PALOMAR ICON AESTHETIC SYSTEM
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