CO2 Laser System

K200042 · Beijing Superlaser Technology Co., Ltd. · GEX · Jun 9, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200042
• Device Name: CO2 Laser System
• Applicant: Beijing Superlaser Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Device Story

CO2 laser system (model SL-LC01) emits 10.6um far-infrared laser for tissue vaporization and coagulation. Device comprises laser source, 7-joint light guide arm for beam delivery, and red diode aiming beam (650nm). Operated in hospital settings by clinicians via touch screen and footswitch. System utilizes closed inner circulating water cooling. Output power (1-30W) and pulse modes (single, continuous, pulse) allow surgical control. Device facilitates precise tissue interaction for various surgical specialties; benefits include controlled ablation and coagulation. No cloud or network connectivity described.

Clinical Evidence

No clinical study performed. Substantial equivalence supported by bench performance testing and software validation/verification.

Technological Characteristics

CO2 laser medium; 10.6um wavelength; 30W max power. 7-joint light guide arm delivery. Red diode aiming beam (650nm, ≤5mW). Closed inner circulating water cooling. Touch screen/footswitch control. Standards: IEC 60601-1 (electrical safety), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for human tissue vaporization and coagulation in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology applications.

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 System (K192528)

Submission Summary (Full Text)

{0}------------------------------------------------

June 9, 2020

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 CN

Re: K200042

Trade/Device Name: 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: May 8, 2020 Received: May 12, 2020

Dear Ray Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K200042

Device Name CO2 Laser System

Indications for Use (Describe)

The CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Section 807.92.

- Date of Preparation 1. 05/07/2020
- 2. Applicant Name and Address Beijing Superlaser Technology Co., Ltd. No.2, Zhongfu Street,Economic and Technological Industrial zone, Xihongmen Tower, Daxing District, Beijing, China.
- 3. Contact Person Information

Shi Shuang Registration Specialist Tel: [phone] to 806 Fax:[phone] Email: [e-mail]

- 4. Submission Correspondent
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: [phone] Fax: [phone] Email: [e-mail]

- 5. Identification of Proposed Device
Trade Name: CO2 Laser System Common Name: Powered Laser Surgical Instrument Model(s): SL-LC01

Classification Name: Powered Laser Surgical Instrument Class: II Product Code: GEX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery

- 6. Identification of the Primary Predicate 510(k) Number: K192528 Device Name: CO2 Laser Therapy System Manufacturer: Shangdong Huamei Technology Co., Ltd.
- 7. Device Description

{4}------------------------------------------------

The device emits CO2 laser at the wavelength of 10.6um, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

- 8. Indications for Use
The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

- 9. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device K192528 | Remark |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Where used | hospital | hospital | SE |
| Intended Use | The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SE |

Tab 1 General Comparison

| Tab 2 Performance Comparison | |
|------------------------------|--|
|------------------------------|--|

| ITEM | Proposed Device | Predicate Device K192528 | Remark |
|----------------------------|-------------------------------------------------------|----------------------------------------------------------------|---------|
| Maximum Power | 30W | 30W | SAME |
| Work Mode | Surgery (Single Pulse, Continuous, Pulse) | Surgery (Single Pulse, Continuous, Muti-Pulse) | SAME |
| Wavelength | 10.6 um | 10.6 um | SAME |
| Beam Delivery | 7 joint light guide arm | 7 knuckle arm key joints light arm | SAME |
| Aiming Beam | Red indicator light (650nm, ≤5 mW) | 630-650nm red diode laser (≤5 mW) | SAME |
| Spot Size | 0.5 mm | 0.5 mm | SAME |
| Output Power | pulse, 1-30W<br>single 1-30W<br>continuous 1-30W | Single Pulse 1-30W<br>Muti-Pulse 1-30W<br>Continuous 1-30W | SAME |
| Pulse Duration | Single Pulse Mode: 1-1000 ms<br>Pulse mode: 1-1000 ms | Single Pulse Mode: 0.1-1000 ms<br>Muti-Pulse Mode: 0.1-1000 ms | SIMILAR |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SAME |
| Laser Operation | Footswitch | Footswitch | SAME |
| Laser medium/energy source | CO2 | CO2 | SAME |
| Cooling System | Closed inner circulating water cooling | Air cooling | SIMILAR |

{5}------------------------------------------------

| Cleaning Method | 70% isopropyl alcohol | 70% medical alcohol | SAME |
|-----------------|--------------------------|--------------------------------|----------|
| Dimension | 37.5 cm x 29 cm x 113 cm | 66*42*125cm(without light arm) | Analysis |
| Weight | 40kg | 80 kg | Analysis |
| Power input | 110V 60Hz or 230V 50Hz | AC 110V/60Hz ; | SIMILAR |

#### Tab 3 Safety Comparison

| Item | Proposed Device | Predicate Device K161925 | Remark |
|----------------------------------|--------------------------------------------|--------------------------------------------|--------|
| EMC, Electrical and Laser Safety | | | |
| Electrical Safety | Comply with IEC 60601-1, IEC<br>60601-2-22 | Comply with IEC 60601-1, IEC<br>60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |

Analysis

The difference between proposed device and predicate device lies in the appearance (dimension, weight) and pulse duration. The difference will not affect the safety and effectiveness of proposed device in comparison to the predicate.

### 10. Non-Clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- . IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22:2012, Medical Electrical Equipment Part 2-22: Particular . Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
- IEC 60825-1: 2014, Safety of laser products Part 1: Equipment classification ● and requirements.
- . IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.

In Addition, the following non-clinical tests were performed to make sure that the device performs as intended:

- Software Validation & Verification Test .
- Bench Performance Tests .

### 11. Clinical Testing

No clinical study is performed to support substantial equivalence.

#### 12. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.