PASTELLE Q-SWITCHED ND: YAG LASER

K123293 · Won Technology Co., Ltd. · GEX · Apr 11, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123293
• Device Name: PASTELLE Q-SWITCHED ND: YAG LASER
• Applicant: Won Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Device Story

Pastelle Q-Switched Nd:YAG laser system; utilizes Nd:YAG crystal to generate laser energy at 532nm and 1064nm wavelengths. Device comprises main body, articulated arm, and foot switch. Operates by delivering short, high-peak-power pulses (6-20ns) to target skin chromophores/pigment for thermal absorption. Used in clinical settings by healthcare professionals for dermatological and surgical procedures. Output energy facilitates tissue incision, excision, ablation, vaporization, coagulation, and hemostasis. Benefits include precise tissue interaction for dermatologic applications.

Clinical Evidence

No clinical data. Bench testing only, including software validation, electrical safety, electromagnetic compatibility, transit testing, and functional testing.

Technological Characteristics

Q-Switched Nd:YAG laser; wavelengths 532nm/1064nm; pulse duration 6-20ns; energy up to 1300mJ (1064nm) and 500mJ (532nm); spot size 2-10mm; power 220V-230V AC, 50/60Hz. System includes main body, articulated arm, and foot switch. Software used for device control/validation.

Indications for Use

Indicated for incision, excision, ablation, and vaporization of soft tissue for general dermatology, dermatologic, and general surgical procedures requiring coagulation and hemostasis.

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

• Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser (K014234)

Reference Devices

• Lutronic Spectra VRMII (K080248)
• HOYA Conbio RevLite Q-Switched Nd:YAG Laser System (K083899)

Submission Summary (Full Text)

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K 123293

## Section 5 510(k) Summary

# APR 1 1 2013

In accordance with 21 CFR 807.92 (Summary):

A summary of the information regarding the safety and effectiveness of the Pastelle Laser System, as required by the Safe Medical Device Amendments of 1990, is provided as follows:

## 510(k) Summary for the WON Technology Co., Ltd. Pastelle Q-Switched Nd: YAG Laser

- 1. Applicant: WON Technology Co., Ltd. WON Technology Co., Ltd. 2. Address: 64 Techno 8-ro Yuseong-gu, Daejeon Republic of Korea 3. Contact Person: Young-Seok Seo (The director of WON Technology Laboratory) [phone]. Telephone: [phone] Fax: E-mail: [e-mail] 5. Preparation Date: October 17, 2012 6. Device Trade Name: Pastelle 7. Common Name: Nd:YAG Laser 8. Classification Name: Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery 9. Legally Marketed Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser Predicate Device: (K014234)

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## 10. Description of the WON Technology Pastelle Q-Switched Nd:YAG Laser:

11. Intended use of the WON Technology Q-Switched Laser:

#### 12. Performance Data:

13. Results of Clinical Study:

Lutronic Spectra VRMII(K080248) HOYA Conbio RevLite Q-Switched Nd: YAG Laaser System (K083899)

The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories.

This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect.

The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.

WON Technology's Pastelle Q-Switched Nd:YAG Laser System is a indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coaqulation and Hemostasis.

Bench studies indicate that the Pastelle device performs as intended. The following bench testing was performed: software validation, electrical safety, electromagnetic compatibility, transit testing and functional testing.

No clinical studies were performed.

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| | WON Technology<br>Pastelle Q-Switched<br>Nd:YAG Laser K123293 | Continuum Electro-<br>Optics, Inc. MedLite C6<br>Q-Switched Nd:YAG<br>Laser K014234 |
|-----------------------|---------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Laser Type | Q-Switched Nd:YAG | Q-Switched Nd:YAG |
| Wavelength | 532nm, 1064nm | 532nm, 1064nm |
| Pulse | Single,0-10Hz ±20% | Single,1, 2, 5 and 10Hz |
| Pulse duration | 6 to 20ns | 5 to 20ns |
| Power requirement | 220V-230V AC, 50/60Hz | 220V AC, 50/60Hz<br>110V AC, 50/60Hz |
| Spot size | 2mm to 10mm<br>Control value: 1mm | 3, 4, 6, 8mm at 1064nm<br>2, 3, 4, 6mm at 532nm |
| Energy per pulse(MAX) | 1300mJ at 1064nm<br>500mJ at 532nm | 1000mJ at 1064nm<br>400mJ at 532nm |

*Summary of Technological Characteristics:

서 약

(Signature of Certifier)

Young-Seok Seo (Director of WON Technology Laboratory) (Typed Name)

October 17, 2012

(Date)

K123293

*Pre-market Notification 510(k)

*For a new submission, leave the 510(k) number blank.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is composed of three stylized, curved lines that resemble a human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

WON Technology Co., Ltd. % Northwest Clinical Research Group, Inc. Roberta Hines. President and CEO 24125 8th Avenue Southeast Woodinville, Washington 98052

#### April 11, 2013

Re: K123293

Trade/Device Name: Pastelle O-Switched Nd: Y AG Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: March 05, 2013

Received: March 18, 2013

Dear Ms. Hines:

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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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#### Page 2 - Roberta Hines, President and CEO

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) Number (if known): K123293

Device Name: Trade Name, Pastelle

Indications for Use

WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

Neil R Ogden 2013.04.08 1:6:06:14 -04'00'

Division Sign-Off for MXM Division of Surgical Devices Office of Device Evaluation 510(k) Number: K123293