(153 days)
Not Found
No
The summary describes a standard CO2 laser system and does not mention any AI or ML components or functionalities.
Yes
The device description and intended use clearly state that it is used for human tissue vaporization and coagulation in various medical specialties, which are therapeutic interventions. Additionally, the predicate device is a "CO2 Laser Therapy System," further indicating its therapeutic purpose.
No
The device description and intended use state that the CO2 Laser System is used for tissue vaporization and coagulation, which are therapeutic rather than diagnostic actions. It does not mention any function for identifying or analyzing medical conditions.
No
The device description explicitly states it emits a CO2 laser at a specific wavelength, indicating it is a hardware device that uses laser technology for tissue treatment. The performance studies also mention compliance with hardware-related standards (IEC 60601 series, IEC 60825-1).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used for human tissue vaporization and coagulation in various surgical specialties. This is a direct treatment/surgical procedure performed on the patient's body.
- Device Description: The description reinforces that the device emits a CO2 laser for the purpose of tissue vaporization and coagulation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, this CO2 Laser System is a therapeutic device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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, IEC 60601-2-22:2012, IEC 60825-1: 2014, IEC 60601-1-2:2014. In Addition, the following non-clinical tests were performed: Software Validation & Verification Test and Bench Performance Tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
-
- Applicant Name and Address Beijing Superlaser Technology Co., Ltd. No.2, Zhongfu Street,Economic and Technological Industrial zone, Xihongmen Tower, Daxing District, Beijing, China.
-
- Contact Person Information
Shi Shuang Registration Specialist Tel: 86-10-81284899 to 806 Fax:86-10-81284899 Email: 672257488@qq.com
-
- 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
- Submission Correspondent
-
- Identification of Proposed Device
Trade Name: CO2 Laser System Common Name: Powered Laser Surgical Instrument Model(s): SL-LC01
- Identification of Proposed Device
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
-
- Identification of the Primary Predicate 510(k) Number: K192528 Device Name: CO2 Laser Therapy System Manufacturer: Shangdong Huamei Technology Co., Ltd.
-
- 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.
-
- 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.
- Indications for Use
-
- 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 | ||
| single 1-30W | |||
| continuous 1-30W | Single Pulse 1-30W | ||
| Muti-Pulse 1-30W | |||
| Continuous 1-30W | SAME | ||
| Pulse Duration | Single Pulse Mode: 1-1000 ms | ||
| Pulse mode: 1-1000 ms | Single Pulse Mode: 0.1-1000 ms | ||
| 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 | 6642125cm(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 | ||
| 60601-2-22 | Comply with IEC 60601-1, IEC | ||
| 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.