GALAXY CO2 LASER SYSTEM

K133915 · Beijing Toplaser Technology Co., Ltd. · GEX · Apr 18, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133915
• Device Name: GALAXY CO2 LASER SYSTEM
• Applicant: Beijing Toplaser Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: Laser skin resurfacing. Treatment of furrows and wrinkles. Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty. Site preparation for hair transplants. The fractional scanner is for treatment of wrinkles and skin resurfacing.

Device Story

CO2-2B Galaxy CO2 Laser System is a surgical laser device for soft tissue management. System components: mainframe (CO2 laser generator, power supply, control/safety systems, cooling), articulated arm, aiming beam, handpieces, and fractional scanner. Principle: generates 10.6µm coherent infrared light; energy absorbed by tissue water causes instantaneous vaporization. Fractional scanner delivers high-speed laser scan with micro spots for controlled treatment depth/area. Operated by clinicians in dermatology, plastic surgery, or general surgery settings. Output is laser energy for ablation, vaporization, excision, incision, and coagulation. Clinical benefit: precise tissue removal and resurfacing for various dermatological and surgical conditions.

Clinical Evidence

Bench testing only. No clinical data required. Device validated against IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, and UL 60601-1 standards.

Technological Characteristics

CO2 laser generator (10.6µm wavelength); articulated arm delivery system; fractional scanner handpiece; cooling system; safety protection system. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, UL 60601-1.

Indications for Use

Indicated for patients requiring soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology, plastic surgery, and general surgery. Procedures include skin resurfacing, wrinkle/furrow treatment, removal of skin lesions (tags, actinic keratosis, keloids, tattoos, telangiectasia, carcinomas, warts, pigmentation), treatment of cysts/abscesses/hemorrhoids, blepharoplasty, and hair transplant site preparation.

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

• eCO2 Laser System (K091115)
• YouLaserCO2 Laser System (K111592)
• Slim Evolution II CO2 Laser and Delivery Device Accessories (K110984)

Submission Summary (Full Text)

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Page 1 of 3

APR 1 8 2014

# 5. 510(k) Summary

CO2-2B Galaxy CO2 Laser System Beijing Toplaser Technology Co., Ltd. (As required by 21 CFR 807.92) K Number: K133915

1. Date Prepared: November 29, 2013

## 2. Sponsor Information:

Beijing Toplaser Technology Co., Ltd. East 3rd Floor, Building M7, No.1 Jiuxiangiao East Road, Chaoyang District, Beijing 100015, China Contract Person: Zhang Xiaosong, General Manager Phone: [phone] Fax: [phone]

#### 3. Proposed Device Information:

Device Common or Usual Name: CO2 Laser Device Trade or Proprietary Name: CO2-2B Galaxy CO2 Laser System Classification Name: Powered Laser Surgical Instrument Requlation Number: 21 CFR 878.4810 Product Code: ONG, GEX Panel: General and Plastic Surgery Model: CO2-2B

#### 4. Predicate Devices:

eCO2 Laser System (K091115), Manufactured by Lutronic Corporation. YouLaserCO2 Laser System (K111592) , Manufactured by Quanta System SpA Slim Evolution II CO2 Laser and Delivery Device Accessories K110984 ) Manufactured by Lasering S.r.I .

## 5. Device Description

Galaxy CO2 Laser System consists of Mainframe, Optical Delivery System, Protective Glasses and Footswitch. Mainframe consists of CO2 laser generator, laser power supply, control device, safety protection system and cooling system. Optical delivery

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system consists of articulated arm, aiming beam, normal handpiece and fractional scanner handpiece.

Galaxy CO2 Laser System produces a beam of coherent infrared light --- 10.6µm laser which is near the peak of tissue water absorption. When the water in the tissue absorbs the laser energy, it heats up. The heating causes instantaneous vaporization of the target issue. Equipped with the scanner, the system delivers a high-speed laser scan with micro spots for optional control of treatment area and depth.

### 6. Intended Use / Indications for Use

Galaxy CO2 Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

Laser skin resurfacing

Treatment of furrows and wrinkles

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos,

telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty

Site preparation for hair transplants

The fractional scanner is for treatment of wrinkles and skin resurfacing.

#### 7. Substantial Equivalence

The Galaxy CO2 Laser System (CO2-2B) shares the same technology, the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate devices, eCO2 laser system (K091115), YouLaser CO2 Laser System (K111592 ) , Slim Evolution II CO2 Laser and Delivery Device Accessories (K110984) .

#### 8. Testing

Galaxy CO2 Laser System (CO2-2B) 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 safetv.

· IEC 60601-2-22: Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.

·IEC 60825-1: Safety of laser products - Part 1: Equipment classification, and requirements

·IEC 60601-1-2: Medical Electrical Equipment -Part 1: General requirements for

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safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

·UL 60601-1:2003 R6.03

# Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verify' that the proposed device, Galaxy CO2 Laser System (CO2-2B) met all design specifications .and was substantially equivalent to the predicate devices. No Clinical Information is required.

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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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, which is a symbol often associated with healthcare.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2014

Beijing Toplaser Technology Company, Ltd. Mr. Zhang Xiaosong General Manager East 3rd Floor Building M7, No. 1 Jiuxianqiao East Road Chaoyang District, Beijing, 100015 CHINA

Re: K133915

Trade/Device Name: CO2-2B Galaxy CO2 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: Class II Product Code: ONG. GEX Dated: January 16, 2014 Received: January 22, 2014

#### Dear Mr. Xiaosong:

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 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 or any i with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Zhang Xiaosong

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### · DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K133915

Device Name CO2-2B Galaxy CO2 Laser System

#### Indications for Use (Describe)

The CO2-2B Galaxy CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

Laser skin resurfacing.

Treatment of furrows and wrinkles.

Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.

Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.

Blepharoplasty.

Site preparation for hair transplants.

The fractional scanner is for treatment of wrinkles and skin resurfacing.

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Neil R Ogden:S
2014.04.18 09:58:37 -04'00'

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