CO2 Laser Therapy System
Device Facts
| Record ID | K192528 |
|---|---|
| Device Name | CO2 Laser Therapy System |
| Applicant | Shangdong Huamei Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Dec 3, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The CO2 Laser Therapy System is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Story
CO2 Laser Therapy System uses 10.6 µm CO2 laser energy to vaporize and coagulate human tissue. Device features 30W maximum power, TEM00 mode structure, and 7-knuckle articulated light arm for beam delivery. Includes 630-650nm red diode aiming beam. Operated in hospital settings by clinicians via touch screen and footswitch. System offers single pulse, multi-pulse, and continuous wave modes. High water absorption of CO2 laser facilitates skin surface peeling and tissue treatment. Air-cooled system. Output affects clinical decision-making by enabling precise surgical ablation and coagulation. Benefits include controlled tissue removal and therapeutic intervention across multiple medical specialties.
Clinical Evidence
No clinical data. Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 verified design specifications and safety.
Technological Characteristics
CO2 laser source; 10.6 µm wavelength; 30W max power; TEM00 mode; 7-knuckle articulated arm; air cooling; touch screen/footswitch control. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2.
Indications for Use
Indicated for human tissue vaporization and coagulation in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology.
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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December 3, 2019
Shangdong Huamei Technology Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 CN
Re: K192528
Trade/Device Name: CO2 Laser Therapy 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 11, 2019 Received: September 13, 2019
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
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
K192528
Device Name CO2 Laser Therapy System
Indications for Use (Describe)
The CO2 Laser Therapy System is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;"></div> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192528
- 1. The Submitter Information
# Shangdong Huamei Technology Co., Ltd. No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205 Contact Person: Xu QingHua Position: General Manager Tel: +86-536-2110001 Fax: +86-536-2109823 Email: xuqh(@yeah.net 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: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com
#### 2. Date of Preparation
11/25/2019
- 3. Identification of Proposed Device
Trade Name: CO2 Laser Therapy System Common Name: Powered Laser Surgical Instrument Model(s): HM-CL200 Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810;
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Review Panel: General& Plastic Surgery;
- Identification of Predicate Device 4.
510(k) Number: K161925 Product Name: CO2 Laser Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd
- 5. Device Description
The CO2 Laser Therapy System is a carbon dioxide laser used in medical and aesthetic industry. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and and then achieve the indications. The proposed device is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
- 6. Indication For Use Statement
The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
- 7. Substantially Equivalent (SE) Comparison
### Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device K161925 | 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 equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | The equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. | SE |
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| ITEM | Proposed Device | Predicate Device K161925 | Remark |
|----------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|----------|
| Maximum Power | 30W | 30W | SAME |
| work mode | Surgery (Single Pulse, Continuous,<br>Muti-Pulse) | Surgery (Single Pulse, Continuous,<br>Muti-Pulse) | SAME |
| Wavelength | 10.6 um | 10.6 um | SAME |
| Mode Structure | TEM00 | TEM00 | SAME |
| Beam delivery | 7 knucklearmkey joints light arm | 7 knucklearmkey joints light arm | SAME |
| Light arm | 1.36m | 1.32m | SIMILAR |
| Handpiece Type | Be part of light arm | Be part of light arm | SAME |
| Aiming Beam | 630-650nm red diode laser (<5 mW) | 650nm red diode laser(0.5 mW) | SAME |
| Spot size | 0.5 mm | 0.5mm | SAME |
| Pulse Setting | Single Pulse<br>0.1-1000ms | Pulse<br>10-1000ms | SIMILAR |
| | Muti-<br>Pulse<br>Time On<br>0.1-1000ms<br>Time Off<br>0.1-1000ms | Repeat<br>Time On<br>10-1000 ms<br>Time Off<br>10-1000 ms | SIMILAR |
| | Continuous<br>1-30W | CW<br>0-30W | SIMILAR |
| Control System | Touch screen, footswitch | Touch screen, footswitch | SAME |
| Laser operation | Footswitch | Footswitch | SAME |
| Laser<br>medium/energy<br>source | CO2 | CO2 | SAME |
| Cooling System | Air cooling | Air cooling | SAME |
| Clean Method | 70% medical alcohol | 70% medical alcohol | SAME |
| Dimension | 66*42*125cm(without light arm) | FG900: 56X54X112 cm;<br>FG900-B: 660X54X32 cm;<br>FG900-C: 46X42X125 cm | Analysis |
| Weight | 80 kg | FG900: 49 kg;<br>FG900-B: 28kg;<br>FG900-C: 34kg | Analysis |
| Power input | AC 110V/60Hz ; | AC 110V/50Hz-60Hz | SAME |
Table 2 Performance Comparison
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| 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 | | | |
#### Table 3 Safety Comparison
### Analysis
The only difference between proposed device and predicate device is appearance (dimension, weight), which are not affect the safety and effectiveness of proposed device. Based on the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
#### 8. Non-Clinical Test Conclusion
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.
- > Software Validation & Verification Test
- 9. Clinical Test Conclusion
No clinical study is included in this submission.
- 10. Conclusion drawn from clinical and non-clinical testing
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
