SPECTRAQUATTRO PULSED LIGHT SYSTEM

K052336 · Amjet Distribution, LLC · GEX · Oct 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052336
• Device Name: SPECTRAQUATTRO PULSED LIGHT SYSTEM
• Applicant: Amjet Distribution, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The SpectraQuattro Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.

Device Story

SpectraQuattro Pulsed Light System is a compact, self-contained phototherapeutic device. It delivers pulsed light (300nm-1400nm) via a handpiece to specific treatment sites. The system includes a control console, power supply, cooling system, and footswitch. Operators use interchangeable light spectrum filters (410-1200nm to 640-1200nm) to target specific dermatological conditions. The device is used in clinical settings by healthcare providers. By delivering optimized light wavelengths to the skin, the system treats vascular and pigmented lesions, removes hair, and manages acne vulgaris. The output is controlled by the operator to achieve therapeutic effects on the skin surface.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Pulsed light system; wavelength range 300nm-1400nm; utilizes interchangeable light spectrum filters (410-1200nm, 530-1200nm, 560-1200nm, 585-1200nm, 640-1200nm); includes control console, power supply, cooling system, and handpiece; standalone device.

Indications for Use

Indicated for treatment of dermatological conditions including vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris in patients requiring phototherapeutic light treatment.

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

• Radiancy, Inc. SkinStation™ Pulsed Light System (K030897, K032205, K051268)
• Palomar Estelux™ Pulsed Light System (K020453)
• CoolTouch, Inc. PRIMA Pulsed Light Therapy System (K041323)

Submission Summary (Full Text)

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0C1 1 1 2005

K052336

## 510(k) Summary

## AMJET Distributing, LLC SPECTRAQUATTRO PULSED LIGHT SYSTEM 510(k) Premarket Notification

| Submitter: | AMJET Distributing, LLC |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1025 Berkshire Road<br>Minneapolis, MN 55437 |
| Contact Person: | Stephen Trinter |
| Telephone: | 612-812-1636 |
| Facsimile: | 651-702-4411 |
| Date Prepared: | August 17, 2005 |
| Device Trade Name: | SpectraQuattro Pulsed Light System |
| Common Name: | Pulsed Light System |
| Classification Name: | Instrument, Surgical, Powered. Laser<br>79-GEX, 21 CFR 878.4810 |
| Legally Marketed Predicate<br>Devices: | Radiancy, Inc. SkinStation™ Pulsed Light System<br>(K030897, K032205. K051268). Palomar Estelux™<br>Pulsed Light System (K020453), CoolTouch, Inc.<br>PRIMA Pulsed Light Therapy System (K041323). |

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| Description of the SpectraQuattro<br>Pulsed Light System: | The SpectraQuattro Pulsed Light System is intended<br>to provide phototherapeutic light to the body. The<br>SpectraQuattro is a compact, self-contained system<br>that delivers a beam of pulsed light at wavelengths<br>of 300nm to 1400nm, which can be optimized at<br>various wavelength ranges and delivered to the<br>treatment site. The system consists of a control<br>console which houses the power supply, cooling<br>system, handpiece that contains the light source,<br>and footswitch. |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the<br>SpectraQuattro Pulsed Light<br>System: | The SpectraQuattro Pulsed Light System is<br>generally indicated to treat dermatological<br>conditions. The SpectraQuattro is specifically<br>indicated for the treatment of vascular lesions,<br>rosacea, hemangiomas, leg veins, hair removal,<br>pigmented lesions, lentigenes, and mild to moderate<br>inflammatory and pustular inflammatory acne<br>vulgaris. |
| Technological Characteristics<br>And Substantial Equivalence: | The SpectraQuattro is a pulsed light system<br>generally indicated for the treatment of<br>dermatological conditions and the specific treatment<br>of vascular lesions, rosacea, hemangiomas, leg<br>veins, hair removal, pigmented lesions, lentigenes,<br>and mild to moderate inflammatory and pustular<br>inflammatory acne vulgaris. SpectraQuattro is<br>substantially equivalent to the Cooltouch PRIMA,<br>and has the same intended use, the same principles<br>of operation and is technologically similar to the<br>Cooltouch PRIMA, with only minor exceptions<br>which do not raise issues in terms of performance,<br>safety or effectiveness. Additionally,<br>SpectraQuattro has the same intended use, similar<br>indications for use the same principles of operation |

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and similar technological characteristics as the Radiancy SkinStation and Palomar Estelux. SpectraQuattro is substantially equivalent to said predicate devices and minor differences between SpectraQuattro and these two systems does not raise any new issues in terms of performance, safety and efficacy.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

OCT 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Amjet Distribution, LLC c/o Ned Devine Responsible Third Pary Official Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K052336 Trade/Device Name: SpectraQuattro™ 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: September 23, 2005 Received: September 26, 2005

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 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.

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## Page 2- Ned Devine

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Signature

رم Mark N. Melkerson Acting 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): K052336

Device Name: SpectraQuattro™ Pulsed Light System

Indications for Use:

The SpectraQuattro™ Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro™ Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.

SpectraQuattro™ comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended:

| Light Spectrum Filter | Indications |
|-----------------------|--------------------------------------------------------------------------|
| 410-1200 | Mild to moderate inflammatory and pustular inflammatory acne<br>vulgaris |
| 530-1200 | pigmented lesions |
| 560-1200 | lentigenes |
| 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins |
| 640-1200 | Hair removal |

| Prescription Use: | <b>X</b> |
|-----------------------------|----------|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (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)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_105233 ما3