ABC HAIR REMOVAL SYSTEM

K060839 · Palomar Medical Technologies, Inc. · OHT · Dec 7, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060839
• Device Name: ABC HAIR REMOVAL SYSTEM
• Applicant: Palomar Medical Technologies, Inc.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

Device Story

ABC Hair Removal System is an over-the-counter light-based device for hair removal. System components include base unit, umbilical cord, handpiece, chiller system with coolant, cleaning wipes, lubricant, and power supply. Device operates by delivering light energy to target hair follicles; intended for use as adjunct to shaving. Periodic treatments required for sustained hair removal. Device used by consumers in home setting. Safety and effectiveness supported by prospective clinical study demonstrating intended function without serious adverse events.

Clinical Evidence

Prospective clinical study conducted to support safety and effectiveness for over-the-counter use. Results demonstrated the system functions as intended with no serious adverse events reported.

Technological Characteristics

Light-based hair removal system. Components: base unit, handpiece, chiller system, power supply. Complies with 21 CFR §1040.10 and 1040.11 performance standards for laser products.

Indications for Use

Indicated for over-the-counter hair removal as an adjunct to shaving, requiring periodic treatments for sustained results.

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

• SpaTouch® PhotoEpilation System (K020856)
• Spectra Hair Removal Laser (K052848)
• Palomar SLP™ 1000 (K013028)

Submission Summary (Full Text)

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060839

## 510(k) Summary ABC Hair Removal System

DEC - 7 2006

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

#### SUBMITTER'S INFORMATION 1.

| NAME: | Palomar Medical Technologies, Inc. |
|----------|-----------------------------------------|
| ADDRESS: | 82 Cambridge Street |
| | Burlington, MA 01803 |
| | Phone: [phone] |
| | Fax: [phone] |
| CONTACT: | Sharon Timberlake, RAC, CCRA |
| | Director, Clinical & Regulatory Affairs |

DATE PREPARED: October 26, 2006

#### 2. DEVICE INFORMATION

| TRADE/PROPRIETARY NAME: | ABC Hair Removal System |
|-------------------------|--------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Light Based Hair Removal System |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21 CFR §878.4810) |

Product Code: GEX

### 3. PREDICATE DEVICES

·

SpaTouch® PhotoEpilation System (K020856) Radiancy (Israel) Ltd.

Spectra Hair Removal Laser (K052848) SpectraGenics, Inc.

Palomar SLP™ 1000 (K013028) Palomar Medical Technologies, Inc.

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# 060839

#### 4. INTENDED USE

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

#### ട്. DEVICE DESCRIPTION

The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components. Details are provided in the Device Description Section of this submission.

#### PERFORMANCE & CLINICAL DATA 6.

The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of the ABC Hair Removal System for over-the-counter use. The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events.

#### 7. SUBSTANTIAL EQUIVALENCE

The ABC Hair Removal System is substantially equivalent to its predicate devices when intended for use for hair removal. The data in this 510(k) notification demonstrate that the ABC System shares the same intended use, and similar design features and functional features, and therefore is substantially equivalent to its predicate devices. Details are provided in the Substantial Equivalence Section of this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2008

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

Re: K060839

Trade/Device Name: ABC Hair Removal 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: OHT Dated: July 24, 2006 Received: July 25, 2006

Dear Ms. Timberlake:

This letter corrects our substantially equivalent letter of December 7, 2006.

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 (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 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 - Ms. Sharon Timberlake, RAC, CCRA

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 continue 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/dsma/dsmamain.html

Sincerely yours,

Neil R.P. Ogden

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): ___ K060839

Device Name: ABC Hair Removal System

Indications for Use:

The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ro

Sign-Off Division of General, Restorative. and Neurological Devices

**510(k) Number** 060835
OR
Over-The-Counter Use X

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

PALOMAR MEDICAL TECHNOLOGIES, INC. ABC HAIR REMOVAL SYSTEM 510(K)

CONFIDENTIAL