PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA

K041323 · New Star Lasers, Inc. · GEX · Nov 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041323
• Device Name: PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

Device Story

CoolTouch PRIMA Pulsed Light Therapy System is a compact, self-contained device for dermatological applications. System components include a control console (power supply, cooling system, cryogen source, microcontroller), a handpiece containing the light source, and a footswitch. The device delivers pulsed light at wavelengths between 300nm and 1400nm to the treatment site. The system is operated by a clinician in a clinical setting. The microcontroller manages light delivery parameters. The output is used by the clinician to perform phototherapy or thermolysis for various skin conditions and hair removal, potentially benefiting patients by addressing the specified dermatological indications.

Clinical Evidence

No clinical data provided. No nonclinical performance data provided.

Technological Characteristics

Compact, self-contained pulsed light system. Wavelength range: 300nm-1400nm. Includes power supply, cooling system, cryogen source, and microcontroller. Handpiece-based light delivery. Controlled via footswitch.

Indications for Use

Indicated for patients requiring treatment of psoriasis, vitiligo, atopic dermatitis, seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

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

• New Star Lasers, Inc. UV-300 Pulsed Light Therapy System
• Radiancy, Inc. SkinStation™ Pulsed Light System
• Palomar Estelux tM Pulsed Light Therapy System

Submission Summary (Full Text)

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NOV 17 2004

### 510(k) SUMMARY

## K 041323

# CoolTouch, Inc.

PRIMA Pulsed Light Therapy System 510(k) Premarket Notification

| Submitter: | CoolTouch, Inc. |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 9085 Foothills Boulevard<br>Roseville, CA 95747 |
| Contact Person: | Donald V. Johnson<br>Vice-President of Operations |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date Prepared: | May 13, 2004 |
| Device Trade Name: | PRIMA Pulsed Light Therapy System |
| Common Name: | Pulsed Light for Thermolysis/Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, Laser.<br>79-GEX, 21 C.F.R. § 878.4810 |
| Legally Marketed Predicate<br>Devices: | New Star Lasers, Inc. UV-300 Pulsed Light Therapy System,<br>Radiancy, Inc. SkinStation™ Pulsed Light System,<br>Palomar Estelux tM Pulsed Light Therapy System. |
| Description of the New Star<br>PRIMA Pulsed Light Therapy<br>System: | The CoolTouch PRIMA Pulsed Light Therapy System is a<br>compact, self-contained system that delivers a beam of pulsed<br>light at wavelengths of 300nm to 1400nm, which can be<br>optimized at various wavelength ranges and delivered to the<br>treatment site. The system consists of a control console unit.<br>which houses the power supply, cooling system, cryogen<br>source, and microcontroller, the handpiece, which contains the<br>light source, and the footswitch. |
| Intended use of the New Star<br>PRIMA Pulsed Light Therapy<br>System: | The CoolTouch PRIMA Pulsed Light Therapy System is<br>indicated for the treatment of psoriasis, vitiligo, atopic<br>dermatitis (eczema), seborrheic dermatitis, vascular lesions,<br>rosacea, hemangiomas, leg veins, hair removal, tattoos,<br>pigmented lesions, pigmented lesions, lentigenes, and mild to |

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Nonclinical Performance Data: None. Clinical Performance Data: None. Additional Information: None requested at this time The CoolTouch PRIMA Pulsed Light Therapy System is Conclusion: substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of psoriasis, vitiligo, atopic dermatitis (eczema) seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

moderate inflammatory acne vulgaris.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes resembling human figures or waves, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 2004

Mr. Donald V. Johnson Vice-President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville. California 95747

Re: K041323

Trade/Device Name: CoolTouch PRIMA Pulsed Light Therapy 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: November 4, 2004 Received: November 5, 2004

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nowea your your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease 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 I ou may a may a 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 - Mr. Donald V. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premarket notincation. The PDA misms of basification 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 If you desire specific advice for your as not 11 - Also, please note the regulation entitled, and Colliact the Office of Companies and (21 the Part 807.97). You may obtain Misoraliums of Icrerchoo to premainsonsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATION FOR USE STATEMENT

KO41323 510(k) Number:

Device Name: CoolTouch PRIMA Pulsed Light Therapy System

Indications for Use:

The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (per 21 CFR 801.109)

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Over-the-Counter Use

Muriam C. Provost

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

510(k) Number k041323