HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM

K083203 · Laseroptek Co., Ltd. · GEX · Apr 28, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083203
• Device Name: HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
• Applicant: Laseroptek Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, excision, ablation, vaporization of soft tissue for general dermatology. Removal or lightening of unwanted hair with or without adjuvant preparation. Tattoo Removal - dark ink: blue and black . - light ink. red - light ink: sky blue - light ink: green Treatment of Vascular Lesions: - port wine birthmarks - telangiectasias . - spider angioma - cherry angioma . - spider nevi Treatment of Pigmented Lesions: - café-au-lait birthmarks . - solar lentiginos . - senile lentiginos . - becker's nevi - freckles - nevus spilus - nevus of ota

Device Story

Helios II Q-Switched Nd:YAG Laser System utilizes Nd:YAG (1064 nm) and frequency-doubled KTP (532 nm) laser technology for dermatological procedures. System components include Nd:YAG crystal gain medium, resonator for beam amplification, and Xe gas lamp pumping source powered by high-pressure power supply. User operates device via GUI to control laser output and repetition rate; microprocessor manages interface between GUI and power supply. Laser energy delivered in contact or non-contact mode to target tissue. Clinical application includes tattoo removal, vascular lesion treatment, and pigmented lesion treatment. Device intended for professional use in clinical settings to achieve tissue ablation or pigment destruction, providing therapeutic benefit for dermatological conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison and performance specification alignment with legally marketed predicate devices.

Technological Characteristics

Q-switched Nd:YAG (1064 nm) and frequency-doubled KTP (532 nm) laser. Gain medium: Nd:YAG crystal. Pumping source: Xe gas lamp. Energy source: High-pressure electrical power supply. Control: Microprocessor-based with GUI. Operation: Contact or non-contact mode.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, or vaporization in dermatology; hair removal/lightening; removal of dark (blue/black) and light (red/sky blue/green) tattoos; treatment of vascular lesions (port wine birthmarks, telangiectasias, spider/cherry angiomas, spider nevi); and treatment of pigmented lesions (café-au-lait birthmarks, solar/senile lentigines, Becker's nevi, freckles, nevus spilus, nevus of Ota).

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

• Fotona QX Nd:VAG/KTP Laser System (K053139)
• Medlite C3 Q Switched Nd:YAG Laser (K011677)
• Medlite C6 Q Switched Nd:YAG Laser (K014234)

Submission Summary (Full Text)

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# 510(K) Summary - K083203

| Applicant: | Laseroptek Co. Ltd. |
|---------------------------|-----------------------------------------------------------------------------------------------|
| Address: | 204 Hyundai I Valley<br>223-12 Sangdaiwon, Jungwon<br>Sungnam, Kyunggi 462-714<br>South Korea |
| Contact Person: | Dr. Hong Chu (President) |
| Telephone / Fax / E-mail: | Tel) 82.31.737.9885~8<br>Fax) 82.31.737.9889<br>E-mail) [e-mail] |
| Submitter: | DPS International |
| Address: | 22750 Hawthorne Blvd., Suite 211<br>Torrance, CA 90505 |
| Contact Person: | Kevin J. Choi |
| Telephone / Fax / E-Mail: | Tel) 310.634.4480<br>Fax) 310.378.8186<br>E-mail) kjchoil [e-mail] |
| Preparation Date: | August 16, 2008 |
| Device Trade Name: | Helios II® Q-Switched Nd:YAG Laser System |
| Common Name: | Nd:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered laser, 79-GEX, 21<br>CFR 878-4810 |

# Helios II® Q-Switched Nd:YAG Laser System

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Los 3203 p-2

510(K) Summary - K083203

## Helios II® Q-Switched Nd:YAG Laser System

| Legally Marketed Predicate Devices: | Fotona QX Nd:VAG/KTP Laser System,<br>K053139, by Fotona d.d.Medlite C3 Q Switched Nd:YAG Laser,<br>K011677, by Continuum Electro-Optics, Inc<br>(now Hoya CouiBio, Inc)Medlite C6 Q Switched Nd:YAG Laser,<br>K014234, by Continuum Electro-Optics, Inc<br>(now Hoya CouiBio, Inc) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the Helios II® Q-<br>Switched Nd:YAG Laser System: | The Helios II® laser system is based on the Nd:YAG<br>(1064 nm) and frequency doubled KTP Nd:YAG<br>(532 nm) laser technology. Three basic elements of<br>operations are as follows:<br><br>1) A Nd:YAG crystal is used as a gain medium<br>which produces a laser beam.<br><br>2) A resonator then amplifies the beam.<br><br>3) A lamp that contains Xe gas is used, as a<br>pumping light source. The lamp requires a<br>high-pressure power source device for<br>operation. When the electric energy<br>generated from the high-pressure power<br>source is induced into the electrode of the<br>lamp, it converts into light energy. This<br>converted light energy pumps the Nd:YAG<br>crystal - a gain medium - and the light<br>exhausted from the crystal is amplified into a<br>specific wavelength light. As it passes<br>between the resonant gases, laser beam<br>radiates to an output unit. |

The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

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### 510(K) Summary - K083203

#### Helios II® Q-Switched Nd:YAG Laser System

Intended Use of the Helios II® Q-Switched Nd:YAG Laser System:

The Helios II® Q-Switched Nd:YAG Laser System delivers continuous wave laser light in the contact or non-contact mode for;

#### · Tattoo Removal

- dark ink: blue and black
- · light ink: red
- light ink: sky blue
- · light ink: green

#### Treatment of Vascular Lesions:

- port wine birthmarks
- · telangiectasias
- · spider angioma
- · cherry angioma
- · spider nevi

#### Treatment of Pigmented Lesions:

- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- freckles
- nevus spilus
- · nevus of ota

#### None

Performance Data:

Conclusion:

The Helios II® Q-Switched Nd:YAG Laser System is substantially equivalent to other existing systems in commercial distribution for treatment of the intended use indication as listed above and share very similar / exactly same performance specification parameters.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2009

Laseroptek Co. Ltd. % DPS International Mr. Kevin J. Choi 22750 Hawthorne Boulevard #211 Torrance, California 90505

Received: April 22, 2009

Re: K083203

Trade/Device Name: Helios II Q-Switched ND: YAG Laser 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: April 20, 2009

Dear Mr. Choi:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Kevin J. Choi

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Mark N. N. elkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083203 p. lot 1

## Indications for Use

510(k) Number (if known):

K083203

Device Name:

Helios II Q-Switched ND:YAG Laser System

Indications For Use:

Incision, excision, ablation, vaporization of soft tissue for general dermatology.

Removal or lightening of unwanted hair with or without adjuvant preparation.

#### Tattoo Removal

- dark ink: blue and black .
- light ink. red
- light ink: sky blue
- light ink: green

#### Treatment of Vascular Lesions:

- port wine birthmarks
- telangiectasias .
- spider angioma
- cherry angioma .
- spider nevi

Treatment of Pigmented Lesions:

- café-au-lait birthmarks .
- solar lentiginos .
- senile lentiginos .
- becker's nevi
- freckles
- nevus spilus
- nevus of ota

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

AND/OR

age 1 of 1

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

**510(k) Number** K083203