GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C

K091664 · Shenzhen Gsd Tech Co., Ltd. · ONF · Nov 16, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091664
• Device Name: GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
• Applicant: Shenzhen Gsd Tech Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Nov 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following: - 1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions. Intense Pulsed Light energy wavelengths from 2. 400nm-1200nm are indicated for the treatment of acne. - energy wavelengths . Chi Intense Pulsed Light from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.

Device Story

GSD Intense Pulsed Light System (GP666C4, GP666C) delivers intense pulsed light (400nm-1200nm) via handpieces; operates on principle of selective photothermolysis; causes thermal damage to target chromophores while sparing normal skin by limiting pulse width below thermal relaxation time of skin. Used in clinical settings for surgical, aesthetic, and cosmetic applications; operated by healthcare professionals. Output consists of pulsed light energy; affects clinical decision-making by providing non-invasive treatment for dermatological conditions; benefits patients through hair removal and lesion/acne treatment.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and adherence to safety standards.

Technological Characteristics

Intense pulsed light system; wavelength range 400nm-1200nm; includes handpieces. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Principle of operation: selective photothermolysis.

Indications for Use

Indicated for patients requiring treatment of acne, benign pigmented lesions, hair removal, or vascular lesions using intense pulsed light energy.

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

• Angelite Family of Intense Pulsed Light System (K083915)
• SkinStation System (K030897)
• Radiancy Mistral Device (K072331)

Submission Summary (Full Text)

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## Section 3 510(k) Summary

NOV 1 & 2009

As required by 807.97

The assigned 510(k) Number is

091664

Page ① of ②

| Sponsor | Shenzhen GSD Tech. Co., Ltd<br>703,Building A, Futian TianAn Hi-tech,<br>Venture Park, Shenzhen, Guang Dong, China, 518040 |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ms. Qiu Xiaoming<br>Tel:[phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission<br>Correspondent | Ms. Diana Hong / Mr. Tarzan Wang<br>Shanghai Mid-Link Business Consulting Co., Ltd<br>Sute 8D, No. 19, Lane 999, Zhongshan No.2 Road(S)<br>Shanghai, 200030, China<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Proposed Product<br>Trade Name<br>Model<br>Product Code:<br>Regulation Number:<br>Device Class: | GSD Intense Pulsed Light System<br>GP666C4 & GP666C<br>GEX<br>21 CFR 878.4810<br>Class II |
| Submission Purpose: | New Device |
| Predicate Device: | Angelite Family of Intense Pulsed Light System (K083915)<br>SkinStation System(K030897)<br>Radiancy Mistral Device(K072331) |
| Device Description | The GSD Intense Pulsed Light System (GP666C4 and<br>GP666C) is an intense pulsed light system which delivers<br>intense pulsed light at a wavelength ranging from<br>400nm-1200nm. Intense Pulsed Light (IPL) systems work on<br>the principles of selective photothermolysis. That is, causing |

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091664 page (2) of (2)

thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

The GSD Intense Pulsed Light system is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2: 2001 with Amendment 1: 2004; Edition 2.1 (Edition 2: 2001 consolidated with Amendment 1:2004)

SE Determination

Test Conclusion

Intended Use/Indication for Use

The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.

The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:

- 1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
Intense Pulsed Light energy wavelengths from 2. 400nm-1200nm are indicated for the treatment of acne.

- energy wavelengths .
Chi Intense Pulsed Light from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.
3-2

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 border and an emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The emblem itself features a stylized representation of a human figure with outstretched arms, symbolizing care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV 16 2009

Shenzhen GSD Tech Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong, General Manager Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road(S) Shanghai, 200030, China

Re: K091664

Trade/Device Name: GSD Intense Pulsed Light System 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: ONF Dated: November 5 2009 Received: November 9, 2009

Dear Ms. Hong:

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 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 - Ms. Diana Hong

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.

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/CDRH0ffices/ucm115809.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulkern

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

Enclosure

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## Indication For Use

510(k) Number (if known): Pending

Device Name: __GSD Intense Pulsed Light System

Indications for Use:

The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver ) pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lessons, hair removal, treatment of vascular lesions as following:

- 1. Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
- 2. Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.

3. Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions

Prescription Use J (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel RP del for nxn
(Division Sign off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091664