THERMACLEAR

K060653 · Dermacare, Inc. · GEX · Oct 24, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060653
• Device Name: THERMACLEAR
• Applicant: Dermacare, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Device Story

ThermaClear is a portable, hand-held, battery-powered (two AA alkaline) device for treating mild to moderate inflammatory acne. The device features a biocompatible treatment tip that delivers a short-duration thermal pulse to the skin. By heating the skin to a precise energy fluence, the device accelerates the resolution of acne lesions. It is intended for over-the-counter use by consumers. The device provides a non-invasive method to manage acne pimples, potentially reducing lesion duration without the risk of burns.

Clinical Evidence

Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment. The study design was a randomized, blinded study. Results confirmed the device is as safe and effective as the predicate devices.

Technological Characteristics

Portable hand-held device; biocompatible treatment tip; powered by two AA alkaline batteries; thermal pulse delivery mechanism. Complies with IEC 60601-1 for EMI emission, susceptibility, and static discharge.

Indications for Use

Indicated for treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

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

• Zeno (K043377)
• Radiancy Acne System With ClearTouch™ (K032205)

Submission Summary (Full Text)

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ThermaClear™ Traditional 510K Document

K060653

0C1 2 4 2006

# 5. 510(k) Summary DermaCare, Incorporated - ThermaClear™ Device

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).

| Owner's Name and Address: | DermaCare, Inc.<br>6248 Preston Avenue<br>Livermore, CA 94551<br>[phone] – Telephone<br>[phone] – Fax |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Heidi Stark<br>DermaCare, Inc.<br>6248 Preston Avenue<br>Livermore, CA 94551<br>[phone] - Telephone<br>[phone] - Fax |
| Date Prepared: | March 2, 2006 |
| Device Trade Name: | ThermaClear™ |
| Common Name: | Acne Treatment Device |
| Classification Name: | Class II - Laser instrument, surgical,<br>powered (21 CFR 878.4810, Product Code<br>GEX) |
| Predicate Devices: | Tyrell, Inc.<br>Zeno<br>K043377<br><br>Radiancy (Israel) Ltd.<br>Radiancy Acne System With ClearTouch™<br>K032205 |

### Description of the Device:

ThermaClear™ is a portable hand-held device that uses a short thermal pulse to treat mild to moderate inflammatory acne. The treatment tip is comprised of biocompatible

> Page 8 Proprietary and Confidential

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### KO60653 ThermaClear™ Traditional 510K Document

material and delivers a short duration thermal pulse that heats the area being treated. The device is powered by two AA alkaline batteries.

#### Indications for Use:

ThermaClear™ is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

#### Performance Data:

Non-clinical and clinical performance testing was conducted with the ThermaClear™ device.

#### Preclinical Testing

ThermaClear™ was tested for EMI in accordance with the IEC 60601-1 standard. ThermaClear™ operates within the EMI emission, susceptibility and static discharge levels specified in the IEC 60601-1 standard.

#### Clinical Testing

Clinical testing was conducted in both a controlled practitioner office environment and a consumer home-use environment and submitted as part of the 510(k) application to confirm that ThermaClear™ is as safe and effective as the predicate device. The controlled clinical study design was a randomized, blinded study.

#### Substantial Equivalence:

ThermaClear™ and its predicate devices are all devices that use either heat or light to treat the dermatological condition of mild to moderate acne by exposing the surface of the skin to a precise energy fluence. The delivered energy heats the skin to accelerate resolution of the acne lesion with no risk of burns. The minor differences in the technological characteristics of ThermaClear™ and its predicate devices do not raise any new issues of safety or efficacy. Thus, ThermaClear™ is substantially equivalent to the predicate device for treatment of mild to moderate acne.

#### Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed device has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure with three flowing lines above it, possibly representing care or support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2006

DermaCare, Inc. % Mr. Peter Scocimara CEO/President 6248 Preston Avenue Livermore, California 94551

Re: K060653

Trade/Device Name: ThermaClear 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 24, 2006

Received: July 26, 2006

Dear Mr. Scocimara:

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 - Mr. Peter Scocimara

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,

ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

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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## 4. Indications for Use Statement

510(k) Number (if known): )</ O 6 6 ( 3

Device Name: ThermaClear

Indications for Use: ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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) |
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signature

(Division Division of General, Restorative, and Neurological De

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