NANNOLIGHT INTENSE PULSED LIGHT SYSTEM

K082033 · Global USA Distribution, LLC · GEX · Jul 31, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082033
• Device Name: NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
• Applicant: Global USA Distribution, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. 530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae 560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae 585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae 640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction 690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

Device Story

NannoLight Intense Pulsed Light System; console-based device with power supply, cooling system, and LCD touch screen interface; handpiece delivers intense pulsed light for selective photothermolysis and hemostasis; operated by clinicians in medical settings; settings for power, pulse width, and pulse count manually adjusted via software-controlled interface; footswitch-activated; provides therapeutic light energy to target skin lesions or hair follicles; benefits include non-invasive treatment of dermatological conditions and hair reduction.

Clinical Evidence

No clinical data.

Technological Characteristics

Console-based intense pulsed light system; includes power supply, electronic circuit board, cooling system, and LCD touch screen; handpiece light source; footswitch control; software-controlled operation; wavelength range 530-1400 nm.

Indications for Use

Indicated for patients with Fitzpatrick skin types I-V requiring selective photothermolysis and hemostasis of soft tissue for benign pigmented/vascular lesions, cutaneous lesions (warts, scars, striae), and hair reduction.

Regulatory Classification

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.

Predicate Devices

• Sciton Profile BBL System (K032460)
• Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems (K020839)

Submission Summary (Full Text)

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K082033 JUL 3 1 2008

# 510(k) Summary

:

## Global USA Distribution, LLC NannoLight Intense Pulsed Light System 510(k) Premarket Notification

| Submitter: | Global USA Distribution, LLC |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Address: | 10723 Aquila Av. S.<br>Minneapolis, MN 55438 |
| Contact Person: | Matt Makousky |
| Telephone: | 952-703-5373 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | April 1, 2008 |
| Device Trade Name: | NannoLight Intense Pulsed Light System |
| Classification Name: | Instrument, Powered, Laser<br>79-GEX, 21 CFR 878.4810 |
| Legally Marketed Predicate<br>Devices: | Sciton Profile BBL System (K032460),<br>Lumenis Family of Intense Pulsed-Light (IPL) and<br>IPL/Nd:YAG Laser Systems (K020839) |

#### Description of the NannoLight Intense Pulsed Light System:

The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.

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#### Intended Use of the NannoLight Intense Pulsed Light System:

The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles)

* Benign cutaneous lesions including warts, scars, and striae

560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

* Benign cutaneous lesions including warts, scars, and striae

585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

* Benign cutaneous lesions including warts, scars, and striae

640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of:

* The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of:

* The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

| Nonclinical Performance<br>Data: | None |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Performance<br>Data: | None |
| Additional Information: | None requested at this time |
| Conclusion: | The NannoLight Intense Pulsed Light System is<br>substantially equivalent to other existing legally<br>marketed laser systems currently in commercial<br>distribution. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096

JUL 3 1 2008

Re: K082033

Trade/Device Name: NannoLight Intense Pulsed Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 15, 2008 Received: July 17, 2008

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -- Mr. Ned Devine

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullean

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): _ ( 082 0 33

Device Name: NannoLight Intense Pulsed Light System

Indications for Use:

The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of;

- * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles)
* Benign cutaneous lesions including warts, scars, and striae

560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

* Benign cutaneous lesions including warts, scars, and striae

585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

* Benign cutaneous lesions including warts, scars, and striae

640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction

690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction.

Prescription Use: 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)

Mark M. Millbern

on of General, Restorative, and Neurological Devices

510(k) Number K082033