CO2 LASER SYSTEM

K101555 · Advanced Technology Laser Co., Ltd. · GEX · Sep 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101555
• Device Name: CO2 LASER SYSTEM
• Applicant: Advanced Technology Laser Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

eBeam CO2 Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures including but not limited to: Laser skin resurfacing Treatment of furrows and wrinkles Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty Site preparation for hair transplants. Dental procedure including but not limited to - Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision); Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis. Podiatry procedures including but not limited to - Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares. Otorhinolaryngology (ENT) procedures including but not limited to - Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. This device is for prescription use only.

Device Story

eBeam CO2 Laser System is a sealed-off CO2 laser (10.6 µm wavelength) for soft tissue surgery. System comprises control unit, user interface, power supply, cooling system, and 7-joint spring-balanced articulated arm with handpieces (scanning/normal). Laser energy delivered via mirrors in articulated arm to handpiece for ablation, vaporization, excision, incision, and coagulation. Operated by physicians in clinical settings. Output is laser beam; provider directs beam to target tissue to achieve surgical effect. Benefits include precise soft tissue management across multiple specialties. Note: safety/effectiveness not evaluated for fractionated scanning.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and adherence to mandatory/voluntary safety standards (IEC 60601 series, 21 CFR 1040.10/11).

Technological Characteristics

Sealed-off CO2 laser; 10.6 µm wavelength. 7-joint spring-balanced articulated arm delivery system. Includes scanning and normal handpieces. Class IV laser. Complies with IEC 60825-1, IEC 60601-2-22, IEC 60601-1, and IEC 60601-1-2. Quality system certified to ISO 9001 and ISO 13485.

Indications for Use

Indicated for patients requiring soft tissue ablation, vaporization, excision, incision, and coagulation across dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and ENT specialties. Specific conditions include skin lesions, dental/periodontal pathologies, podiatric lesions, and gynecological/ENT soft tissue conditions. Prescription use only.

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

• SLIM Evolution Family of CO2 Laser and Delivery Device Accessories (K063001)

Submission Summary (Full Text)

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K101555
SEP 1:7 2010

ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report-510(k) summary

# Section III. 510(k) summary

eBeam CO2 Laser System

Advanced Technology Laser Co., Ltd

# (As required by 21 CFR 807.92)

# 1. Date Prepared: March 22, 2010

# 2. Sponsor Information

Advanced Technology Laser Co., Ltd 920 Jian-Chuan Road, Bldg. A2, Level 5 Shanghai, 200240, China

Contact Person: Jing Wang, Registration specialist Phone: [phone](ext:837) Fax: [phone]

# 3. Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai,200030, China Tel: [phone] Fax: [phone] Email: [e-mail]

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -510(k) summary

# 4. Proposed Device Information

Device Common or Usual Name: Carbon dioxide laser; Device Trade or Proprietary Name: eBeam CO2 Laser System Model: eBeam Classification Name: Laser instrument, Surgical, Powered Regulation Number: 21 CFR 878.4810 Product Code: GEX Panel: 878 General and Plastic Surgery

### 5. Predicate Device

SLIM Evolution Family of CO2 Laser and Delivery Device Accessories (K063001)

## 6. Device Description

eBeam CO2 Laser System is an intelligent sealed-off CO2 laser. eBeam CO2 Laser System delivers laser energy to the treatment site via a 7-joint spring-balanced articulated arm in which mirrors reflect the laser beam along the axis of arms to enter the output device- the specially designed handpiece.

eBeam CO2 Laser System can produce a laser beam with a wavelength of 10.6 m which is effective on all soft tissues, thus it can be used in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic(dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.

eBeam CO2 Laser System consists of control system, user interface, power supply, laser emission and delivery system, cooling system, safety features and handpieces (including scanning handpiece and normal handpiece).

#### 7. Intended use

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#### ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report-510(k) summary

eBeam CO2 Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery, gynecology, podiatry, dental and otorhinolaryngology.

#### 8. Substantial Equivalence

eBeam CO2 Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, SLIM Evolution Family of CO2 Lasers and Delivery Device Accessories (K063001). In addition, a review of the predicate device demonstrate that eBeam CO2 Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.

### 9. Testing

eBeam CO2 Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:

- IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification, . requirements and user's guide.
- IEC 60601-2-22: 2007, Medical Electrical Equipment Part 2: Particular . requirements for the safety of diagnostic and therapeutic laser equipment.
- IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment Partl: ● General requirements for safety.
- IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment Part 1: General ● requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests.

The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification.

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -510(k) summary

#### Non-Clinical Conclusion:

Laboratory testing was conducted to validate and verify that the proposed device, eBeam CO2 Laser System met all design specifications and was substantially equivalent to the predicate device.

Clinical Conclusion: No Clinical Information is required

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

Advanced Technology Laser Co., Ltd. % Underwriters Laboratories, Inc. Laboratory and Testing Mr. Marc M. Mouser 2600 N.W. Lake Road Camas, Washington 98607-9526

SEP 1 7 2010

Re: K101555

Trade/Device Name: eBeam 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: GEX Dated: September 08, 2010 Received: September 09, 2010

Dear Mr. Mouser:

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.

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#### Page 2 - Mr. Marc M. Mouser

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 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/CDRHOffices/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Dep D.R

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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×101555 SEP 1 7 2010

DVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -Indications for Use Statement

# Attachment IV Indications for Use Statement

510(k) Number: K101555 Device Name:

eBeam CO2 Laser System

#### Indications for Use:

eBeam CO2 Laser System are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), general surgery ,gynecology,podiary,dental and otorhinolaryngology

Dermatology, Plastic Surgery and General Surgery procedures including but not limited to:

Laser skin resurfacing

Treatment of furrows and wrinkles

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

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

Blepharoplasty

Site preparation for hair transplants

#### Dental procedure including but not limited to -

Periodontal procedures such as - gingivectomy, removal of hyperplasias gingivoplasty (incision and excision);

Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign /malignant lesion ablation, operculectomy and homeostasis

Over-The-Counter Use Prescription Use _ AND/OR X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

CDRH. Office of Device Evaluation (ODE) Concurrence of

Neil R. Oyler Co.

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 2

510(k) Number. K101555

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Image /page/7/Picture/0 description: The image shows the logo for Advanced Technology Laser Co., LTD. The logo includes the letters ATL inside of a circle. Below the logo, the text "510(k) Submission Report -Indications for Use Statement" is visible. The text is left-aligned and in a smaller font size than the company name.

#### Continued from Previous Page

#### Podiatry procedures including but not limited to -

Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares.

#### Otorhinolaryngology (ENT) procedures including but not limited to -

Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps.

#### Gynecology

Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.

This device is for prescription use only.

The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.

AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

NielReOgle for mxm

- Orvision of Surgical, Orthopedic, Restorative Devic
510(k) Number K101555