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

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.

AI/ML Overview

This FDA 510(k) summary describes a CO2 Laser System by Beijing Superlaser Technology Co., Ltd. and seeks to demonstrate its substantial equivalence to a predicate device (K192528).

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" as a separate section with specific thresholds. Instead, the substantial equivalence is based on a comparison to a predicate device, showing that the proposed device performs "the same" or "similarly" across various specifications and complies with relevant safety standards.

Here's a table based on the "Performance Comparison" and "Safety Comparison" sections, with "Reported Device Performance" being the specifications of the Proposed Device and "Acceptance Criteria" being implicitly met if it's "SAME" or "SIMILAR" to the Predicate Device, or complies with established standards.

Item	Acceptance Criteria (Predicate or Standard)	Reported Device Performance (Proposed Device)	Remark
General
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	Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	Human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	SE
Performance
Maximum Power	30W	30W	SAME
Work Mode	Surgery (Single Pulse, Continuous, Muti-Pulse)	Surgery (Single Pulse, Continuous, Pulse)	SAME
Wavelength	10.6 um	10.6 um	SAME
Beam Delivery	7 knuckle arm key joints light arm	7 joint light guide arm	SAME
Aiming Beam	630-650nm red diode laser (≤5 mW)	Red indicator light (650nm, ≤5 mW)	SAME
Spot Size	0.5 mm	0.5 mm	SAME
Output Power	Single Pulse 1-30WMuti-Pulse 1-30WContinuous 1-30W	pulse, 1-30Wsingle 1-30Wcontinuous 1-30W	SAME
Pulse Duration	Single Pulse Mode: 0.1-1000 msMuti-Pulse Mode: 0.1-1000 ms	Single Pulse Mode: 1-1000 msPulse mode: 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	Air cooling	Closed inner circulating water cooling	SIMILAR
Cleaning Method	70% medical alcohol	70% isopropyl alcohol	SAME
Safety and Standards Compliance
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

The study (non-clinical testing) states that "The test results demonstrated that the proposed device complies with the following standards" for safety and that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implicitly means the device meets the acceptance criteria of conforming to the predicate device's performance characteristics and a set of recognized electrical, EMC, and laser safety standards.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not applicable. The document describes non-clinical bench testing and software validation, not a study with a "test set" of patient data or images.
Data provenance: Not applicable, as there isn't patient data/images involved in this type of submission. The tests are bench tests performed in a laboratory setting by the manufacturer. The company is based in Beijing, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission is for a CO2 Laser System that performs surgical functions, not an AI/imaging device requiring expert consensus for ground truth on diagnostic interpretations. The "ground truth" for this device would be its physical performance specifications and adherence to safety standards, verified through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as there is no "test set" in the context of clinical or image-based studies requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is a physical CO2 laser system, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm. The device performance is assessed through its physical operation and compliance with engineering standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance and safety is established through:

Engineering specifications and measurements: Comparing output power, wavelength, spot size, etc., against the predicate device's documented specifications.
Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 for electrical, EMC, and laser safety.
Bench Performance Tests: These would involve direct measurements of the device's output and function.
Software Validation & Verification Test: Ensuring the control system software operates correctly according to its design specifications.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set.

Summary

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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

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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

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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)

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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
1. Applicant Name and Address Beijing Superlaser Technology Co., Ltd. No.2, Zhongfu Street,Economic and Technological Industrial zone, Xihongmen Tower, Daxing District, Beijing, China.
1. Contact Person Information

Shi Shuang Registration Specialist Tel: 86-10-81284899 to 806 Fax:86-10-81284899 Email: 672257488@qq.com

1. 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
1. 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

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

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1. 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.
1. 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, 1-30Wsingle 1-30Wcontinuous 1-30W	Single Pulse 1-30WMuti-Pulse 1-30WContinuous 1-30W	SAME
Pulse Duration	Single Pulse Mode: 1-1000 msPulse mode: 1-1000 ms	Single Pulse Mode: 0.1-1000 msMuti-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

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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, IEC60601-2-22	Comply with IEC 60601-1, IEC60601-2-22	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.

Regulation Number and Section

§ 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.