DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS

K052371 · Hair International Systems USA, Inc. · GEX · May 4, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052371
• Device Name: DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
• Applicant: Hair International Systems USA, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Depilite EL-8b DERMO FLASH™ Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. The Depilite EL-8b DERMO FLASH™ Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Device Story

Microprocessor-controlled nonablative light-based system; utilizes pulsed xenon lamps to deliver polychromatic light (visual and infrared spectrums) for photothermolysis. System components include main unit with display/control panel, air-cooled double lamp handpiece, foot switch, and protective goggles. Operator (clinician) selects parameters—wavelength, energy, pulse rate, exposure time—via control panel. Energy delivered via non-contact pulsed light (NCPL™) to target area. Used in clinical dermatology settings for hair reduction and lesion/acne treatment. Output provides therapeutic photothermolysis; clinical benefit includes permanent hair reduction and skin lesion/acne management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Microprocessor-controlled nonablative xenon flash lamp system. Delivers polychromatic light (visual/infrared). Features air-cooled double lamp handpiece for non-contact delivery. Compliant with 21 C.F.R. Part 1040. System includes main unit, handpiece, foot switch, and power cables.

Indications for Use

Indicated for permanent hair reduction, treatment of vascular and benign pigmented lesions, and inflammatory acne in patients with skin types I-IV.

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

• Clareon™ Pulsed Light System Solarus™ Pulsed Light System (K043319)
• ProLite / Plasmalite MPX Pulsed Light System (K023081)
• Flash 1 (K022583)
• EpiLight® PhotoDerm® HR (K991935)

Submission Summary (Full Text)

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## 510(k) Number K052371

MAY - 4 2006

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

510(k) Summary Statement for MED-OP Aesthetic Technologies, Ltd. Depilite EL-8b Series DERMO FLASH™ Systems

Regulatory Authority:

Safe Medical Devices Act of 1990, Title 21 C.F.R. Section 807.92

Submitter's Name:

Hair International Systems USA, Inc. 11526 Sorrento Valley Road, Suite IB San Diego, California 92121 Tel: [phone] Fax: [phone]

Contact Person:

Amnon Zakay, President and CEO

Name of Devices:

Depilite EL-8b Series DERMO FLASH™ Systems (and Delivery Accessories):

- DERMO FLASH™ Model A .
- . DERMO FLASH™ Model SX-513 A
- . DERMO FLASH™ Model SX-513 C
- . DERMO FLASH™ Model C

Common Names:

Dermatology Flash Lamp Systems

Section II - Page 1 of 3

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## 510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006

## Classification:

Laser surgical instrument for use in general and plastic surgery and in dermatology. Title 21 C.F.R. Section 878.4810

Medical Specialty - General & Plastic Surgery

Device Class II - Special Controls

Product Code - GEX

Panel - 79

#### Equivalent Devices:

Light-Emitting Source: Flash Lamp Intense Pulsed Light (IPL) Technology:

- . Clareon™ Pulsed Light System Solarus™ Pulsed Light System Novalis Medical, LLC K043319, Dec. 17, 2004
- . ProLite / Plasmalite MPX Pulsed Light System Medical Bio Care Nordic AB K023081, Dec. 16, 2002
- Flash 1 . emed, Inc. K022583, Oct. 31, 2002
- . EpiLight® PhotoDerm® HR ESC Medical Systems, Ltd. K991935, January 27, 2000

Section II - Page 2 of 3

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f 2371

510(K) PREMARKET NOTIFICATION Depilite EL-8b Series DERMO FLASH™ Systems MED-OP Aesthetic Technologies, Ltd. March 20, 2006

# Description of the DERMO FLASH™ Series Devices:

The Depilite EL-8b Series DERMO FLASH™ devices are microprocessorcontrolled nonablative light-based medical devices which use pulsed xenon lamps to deliver a selectable range of polychromatic light outside the range of harmful ultraviolet wavelengths leaving only the visual and infrared light to be presented for photo thermolysis epilation and skin treatments. Pre-set and manual delivery parameters - such as the appropriate wavelength, energy, pulse rate and exposure time - and other system features are modulated from the display and control panel on the main unit. The corresponding fluence is delivered through an air-cooled double lamp hand piece without making contact with the treated area (Non Contact Pulsed Light or NCPL™). The complete system consists of the Depilite EL-8b DERMO FLASH™ machine, a photothermolysis handle with treatment head, keys for main switch, a foot switch, electric power cable, protective goggles, and instruction manual,

The Depilite EL-8b Series DERMO FLASH™ devices are in compliance with mandatory special controls as required by 21 C.F.R. Part 1040 – Performance Standards for Light-Emitting Products.

Indications for Use:

The Depilite EL-8b Series DERMO FLASH™ Systems are microprocessorcontrolled nonablative light-based medical devices designed for permanent hair reduction, and the treatment of vascular and benign pigmented lesions and inflammatory acne, on skin types I-IV.

#### Substantial Equivalency:

The differences in specifications of the Depilite EL-8b Series DERMO FLASH™ devices and the predicate device(s) do not result in different performances or raise new questions of safety or efficacy.

#### Conclusion:

The Depilite EL-8b Series DERMO FLASH™ Systems are substantially equivalent to other legally-marketed flash light-based medical devices in U.S. commercial distribution for the same dermatological applications.

Section II - Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2006

Hair International Systems USA, Inc. c/o Horton, Whiteley & Cooper Mr. Craig A. Mitchell 4590 Macarther Boulevard - Suite 500 15770 Laguna Canyon Road Newport Beach, California 92692

Re: K052371 Trade/Device Name: Depilite EL-8B Series DERMO FLASH™ System DERMO FLASH" Model A M DERMO FLASH' Model SX-513 A DERMO FLASH™ Model SX-513 C DERMO FLASH™ Model C 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: April 21, 2006 Received: April 25, 2006

Dear Mr. Mitchell:

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, J rug, 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.

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### Page 2 - Mr. Craig A. Mitchell

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 maution wour not not incant or any Federal statutes and regulations administered by other Federal agencies. You must CED Dec 20T 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 1000-1000. 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 (21 cr regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Stoull 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,

Hukukemena

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): | 510(k) Number K052371 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Depilite EL-8b Series DERMO FLASH ^TM Systems |
| Indications For Use: | The Depilite EL-8b DERMO FLASH ^TM Model A system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. |
| | The Depilite EL-8b DERMO FLASH ^TM Model SX-513a system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction. |
| | The Depilite EL-8b DERMO FLASH ^TM Model SX-513c system is a microprocessor-controlled nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne. |

Prescription Use __ X (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)

Hubert Humphrey

(Division Sign-Off) (Division of General, Restorative,
Division of General, Restorative, Page 1 of _1 and Neurological Devices

71004) **Number** K052371

- Caller Baker Sa

1. 1. 1

.

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# Indications for Use

510(k) Number (if known):

510(k) Number K052371

Device Name: Depilite EL-8b DERMO FLASH™ Systems

Indications For Use:

And The France of the comments of

The Depilite EL-8b DERMO FLASH™ Model C system is a microprocessor-controlled dual nonablative xenon flash lamp-based medical device designed for permanent hair reduction, and treatment of vascular and benign pigmented lesions and inflammatory acne.

Page 2 of 2

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