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 Description

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the CO2 Laser Therapy Systems (K162398). The submission focuses on demonstrating substantial equivalence to a predicate device (CO2 Laser Therapy Machine, K161925) rather than providing a study where the device meets specific performance acceptance criteria from a clinical trial.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because such a study is not part of this 510(k) summary. Instead, the document provides non-clinical performance data (biocompatibility, electrical safety, EMC, and software verification/validation) to support safety and effectiveness and substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

This document does not present a table of specific acceptance criteria (e.g., specific clinical performance metrics like sensitivity, specificity, accuracy, or a reduction in wrinkles of a certain percentage) that the device was evaluated against in a clinical study. Instead, the performance data provided are non-clinical performance tests demonstrating compliance with recognized standards.

Acceptance Criteria Category	Reported Device Performance (Non-Clinical)
Biocompatibility	Complies with ISO 10993-1. Passed tests for Cytotoxicity, Sensitization, and Irritation for skin and subcutaneous tissue contact (< 24 hours).
Electrical Safety	Complies with IEC 60601-1 (standard for safety).
EMC (Electromagnetic Compatibility)	Complies with IEC 60601-1-2 (standard for EMC).
General Performance	Complies with IEC 60825-1 (for laser product safety).
Software V&V	Software verification and validation conducted; documentation provided per FDA guidance. Software classified as "moderate" level of concern.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or patient data (retrospective or prospective) was used for this 510(k) submission. The performance testing described is non-clinical (biocompatibility, electrical safety, EMC, software).

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

Not applicable. No clinical test set requiring expert-established ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This device is a CO2 laser therapy system, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

Not applicable. This device is a CO2 laser therapy system, not an AI algorithm.

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

Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission as no clinical studies were performed. The "ground truth" for the non-clinical tests was compliance with the specified international standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. This is a physical medical device (CO2 laser).

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

Not applicable. As noted above, this is not an AI/machine learning device.

Summary of what the document does provide regarding device performance:

The document focuses on demonstrating that the CO2 Laser Therapy Systems is substantially equivalent to a predicate device (K161925) and meets all applicable non-clinical safety standards. This is the primary method for demonstrating safety and effectiveness in a 510(k) submission when clinical studies are not deemed necessary by the FDA.

Comparison of Technological Characteristics: A detailed table compares the proposed device with the predicate device across various specifications (Output power, Work mode, Laser medium/energy source, CO2 laser wavelength, Aiming Beam wavelength and power, Spot Size, Dot Quantity, Pulse Energy, Pulse Length, Cooling, Patient contact sites, Control System, Laser Operation, Power input). The conclusion is that differences do not raise new questions of safety and effectiveness.
Non-Clinical Performance Data:
- Biocompatibility: The device components that contact the patient were tested and found to be biocompatible according to recognized standards (ISO 10993-1).
- Electrical Safety & EMC: The device complies with IEC 60601-1 and IEC 60601-1-2 standards, ensuring electrical safety and electromagnetic compatibility.
- General Performance Testing: The device was tested according to IEC 60825-1, a standard for the safety of laser products.
- Software Verification and Validation: Software testing was conducted, and it was deemed a "moderate" level of concern, with documentation provided as per FDA guidance.
No Clinical Studies: The submission explicitly states, "The subject of this premarket submission, CO2 Laser Therapy Systems, does not require clinical studies to support substantial equivalence." This is why there is no information on clinical acceptance criteria or studies.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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: +86-(0)10-57734966

Fax: +86-(0)10-82290038

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6232 1333
	Fax: (+86) 20-8633 0253
Secondary Contact Person:	Xin Wang
	Quality Manager
	Beijing Sincoheren Science and Technology Development
	Co., Ltd.
	Tel: (+86) 10-82294249-8002
	Fax: (+86) 10-82294249-8007
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.

V. INDICATIONS FOR USE

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 Scienceand TechnologyDevelopment Co., Ltd.	Beijing ADSS DevelopmentCo., Ltd	N/A
Device name	CO2 Laser Therapy System	CO2 Laser Therapy Machine	N/A
Intended use	The equipment is used forhuman tissue vaporization,coagulation indermatology, plasticsurgery, and generalsurgery. The fractionalscanner is only for thetreatment of wrinkles andskin resurfacing.	The equipment is used forhuman tissue vaporization,coagulation in dermatologyand plastic surgery, generalsurgery, gynecology,podiatry, dental andotorhinolaryngology.	Smaller intended use.The difference does notraise different questions ofsafety and effectiveness.
Specification	Proposed device	Predicate device	Discussion of Differences
Output power(Maximum)	30W	30W	Identical
Work mode	Scan (Single Pulse,Continuous, Muti-Pulse)	Surgery (Single Pulse,Continuous, Muti-Pulse)	Identical
Laser medium/energysource	CO2	CO2	Identical
CO2 laser wavelength	10600nm	10600nm	Identical
Aiming Beamwavelength	Red diode laser635 nm	Red diode laser650 nm	Similar aiming beamwavelength.The difference does notraise different questions ofsafety and effectiveness.
Aiming Beam power	< 5mW	0.5 mW	Larger aiming beam power,brighter aiming indicator, tomake the operation visionclearer.5mW does not cause heator energy hazard to thepatients during thetreatment procedure.The difference does notraise different questions ofsafety 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 foreach dot	1mj-100mj is optional foreach 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.Both devices complied withIEC 60601-1.
Specification	Proposed device	Predicate device	Discussion of Differences
			The difference does notraise different questions ofsafety 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.

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.