CO2 Laser Therapy Systems

K162398 · Beijing Sincoheren Science and Technology Development Co. · ONG · Jul 6, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162398
• Device Name: CO2 Laser Therapy Systems
• Applicant: Beijing Sincoheren Science and Technology Development Co.
• Product Code: ONG · General, Plastic Surgery
• Decision Date: Jul 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

Device Story

CO2 laser therapy system (10600nm wavelength) utilizes selective photothermolysis to vaporize and coagulate skin tissue; water in tissue absorbs laser energy, causing immediate evaporation/gasification of lesions. System comprises console, articulated arm, and footswitch. Operated by clinicians in dermatology, plastic surgery, or general surgery settings. Parameters (energy, pulse length) set via touch screen based on thermal relaxation time to protect healthy tissue. Fractional scanner mode used for skin resurfacing and wrinkle treatment. Output power 30W; aiming beam (635nm red diode) assists visualization. Device provides non-invasive or minimally invasive tissue ablation, benefiting patients through precise lesion removal and skin rejuvenation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1).

Technological Characteristics

CO2 laser (10600nm); 30W max output; air cooling; articulated arm delivery; red diode aiming beam (635nm, <5mW). Control system: touch screen and footswitch. Power: 110-240VAC, 50-60Hz. Software: moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 10993-1.

Indications for Use

Indicated for human tissue vaporization and coagulation in dermatology, plastic surgery, and general surgery; fractional scanner indicated for treatment of wrinkles and skin resurfacing.

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

• CO2 Laser Therapy Machine (K161925)

Submission Summary (Full Text)

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

July 6, 2017

Beijing Sincoheren Science and Technology Development Co. % Mr. Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd 7th Floor, Jingui Business Building, No.982 Congyun Rd Baiyun District Guangzhou, 510420 China

Re: K162398

Trade/Device Name: Co2 Laser Therapy Systems 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: June 16, 2017 Received: June 19, 2017

Dear Mr. Gu:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (21 CFR 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, Jennifer R. Stevenson -

# S3

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

Enclosure

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## Indications for Use

510(k) Number (if known) K162398

Device Name CO2 Laser Therapy Systems

Indications for Use (Describe)

The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is a green square with a white design on it. The white design appears to be a stylized letter or symbol, possibly a combination of curved and straight lines. The design is abstract and does not resemble any common object or shape. The overall impression is a simple, modern logo or icon.

## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

#### SUBMITTER l.

Beijing Sincoheren Science and Technology Development Co., Ltd. Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044, China Phone: [phone]

Fax: [phone]

| Primary Contact Person: | Mike Gu |
|---------------------------|-------------------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Xin Wang |
| | Quality Manager |
| | Beijing Sincoheren Science and Technology Development |
| | Co., Ltd. |
| | Tel: [phone]-8002 |
| | Fax: [phone]-8007 |
| Date prepared: | Aug 20, 2016 |

II. DEVICE

| Name of Device: | CO2 Laser Therapy Systems |
|-----------------------|-----------------------------------------------------|
| Common/Usual Name: | CO2 Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |

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Image /page/4/Picture/1 description: The image is a green square with a white design on it. The white design appears to be a stylized letter or symbol, possibly a combination of curved and straight lines. The design is not easily recognizable as a standard letter or symbol. The overall impression is a simple, abstract logo or icon.

#### III. PREDICATE DEVICE

## CO2 Laser Therapy Machine, K161925

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

#### DEVICE DESCRIPTION IV.

The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.

#### V. INDICATIONS FOR USE

The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Specification | Proposed device | Predicate device | Discussion of Differences |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K162398 | K161925 | N/A |
| Manufacturer | Beijing Sincoheren Science<br>and Technology<br>Development Co., Ltd. | Beijing ADSS Development<br>Co., Ltd | N/A |
| Device name | CO2 Laser Therapy System | CO2 Laser Therapy Machine | N/A |
| Intended use | The equipment is used for<br>human tissue vaporization,<br>coagulation in<br>dermatology, plastic<br>surgery, and general<br>surgery. The fractional<br>scanner is only for the<br>treatment of wrinkles and<br>skin resurfacing. | The equipment is used for<br>human tissue vaporization,<br>coagulation in dermatology<br>and plastic surgery, general<br>surgery, gynecology,<br>podiatry, dental and<br>otorhinolaryngology. | Smaller intended use.<br>The difference does not<br>raise different questions of<br>safety and effectiveness. |
| Specification | Proposed device | Predicate device | Discussion of Differences |
| Output power<br>(Maximum) | 30W | 30W | Identical |
| Work mode | Scan (Single Pulse,<br>Continuous, Muti-Pulse) | Surgery (Single Pulse,<br>Continuous, Muti-Pulse) | Identical |
| Laser medium/energy<br>source | CO2 | CO2 | Identical |
| CO2 laser wavelength | 10600nm | 10600nm | Identical |
| Aiming Beam<br>wavelength | Red diode laser<br>635 nm | Red diode laser<br>650 nm | Similar aiming beam<br>wavelength.<br>The difference does not<br>raise different questions of<br>safety and effectiveness. |
| Aiming Beam power | < 5mW | 0.5 mW | Larger aiming beam power,<br>brighter aiming indicator, to<br>make the operation vision<br>clearer.<br>5mW does not cause heat<br>or energy hazard to the<br>patients during the<br>treatment procedure.<br>The difference does not<br>raise different questions of<br>safety and effectiveness. |
| Spot Size (Fractional) | 0.5mm | 0.5 mm | Identical |
| Dot Quantity | 400 dots at most | 400 dots at most | Identical |
| Pulse Energy | 1mj-100mj is optional for<br>each dot | 1mj-100mj is optional for<br>each dot | Identical |
| Pulse Length | 200μs-500μs is optional | 200μs-500μs is optional | Identical |
| Cooling | Air cooling | Air cooling | Identical |
| Patient contact sites | Skin | Skin | Identical |
| Control System | Touch screen, footswitch | Touch screen, footswitch | Identical |
| Laser Operation | Footswitch | Footswitch | Identical |
| Power input | 110-240VAC, 50-60Hz | AC 110V/50-60Hz | Similar.<br>Both devices complied with<br>IEC 60601-1. |
| Specification | Proposed device | Predicate device | Discussion of Differences |
| | | | The difference does not<br>raise different questions of<br>safety and effectiveness. |

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Image /page/5/Picture/0 description: The image is a close-up of a logo or symbol set against a green background. The logo features stylized white lines that appear to form an abstract shape, possibly representing a stylized letter or a design element. The white lines are thick and curved, creating a sense of movement and fluidity within the confined space of the image.

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Image /page/6/Picture/1 description: The image is a close-up of a logo or symbol. It features a green square background with a white design on top. The white design appears to be an abstract representation of a person or figure, possibly in motion, with stylized lines suggesting arms or limbs. The overall impression is modern and minimalist.

According to the above comparison table, the proposed device is identical to the predicate device in maximum output power, working mode, laser medium, CO2 laser wavelength, fractional spot size, dot quantity, pulse energy, pulse length, patient contact sites, and laser operation. The proposed device has a smaller intended use, a larger aiming beam power, similar aiming beam wavelength and similar power input, when compared with the predicate device. However, these differences do not raise different questions of safety and effectiveness.

Beijing Sinoheren Science and Technology Development Co., Ltd believes that the CO2 Laser Therapy Systems is as safe and effective, and performs in a substantially equivalent manner to the predicate device.

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing

The biocompatibility evaluation for the CO2 Laser Therapy Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation

The treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours.

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the CO2 Laser Therapy Systems. The device complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.

### Performance testing

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Image /page/7/Picture/0 description: The image is a close-up of a logo or emblem set against a green background. The logo features stylized white lines that resemble a combination of abstract shapes and possibly a letter. The lines are thick and curved, creating a dynamic and fluid design. The overall impression is modern and minimalist, with the white lines standing out against the solid green backdrop.

Performance testing was conducted on the device according to IEC 60825-1.

### Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

### Animal Study

The subject of this premarket submission, CO2 Laser Therapy Systems, does not require clinical studies to support substantial equivalence.

#### VIII. CONCLUSION

The non-clinical data support the safety of the device and the performance testing report demonstrate that the CO2 Laser Therapy Systems should perform as intended in the specified use conditions. Beijing Sincoheren considers the CO2 Laser Therapy Systems does not raise any new issues of safety or effectiveness.