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

Device Description

The Dermatological Carbon Dioxide Laser Systems, and it is also a gas laser. With its own wavelength of 10600 nm, the laser energy density is high and the divergence angle is very small. The focus light beam was used to vaporization, coagulation the human tissue.

AI/ML Overview

The provided document is a 510(k) summary for a Dermatological Carbon Dioxide Laser System. This document does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a physical medical device (a laser system) to a predicate device through non-clinical testing and comparison of technical specifications.

Therefore, many of the requested criteria related to AI/ML study design (ground truth, expert readers, MRMC studies, training/test sets, etc.) are not applicable to this submission.

However, I can extract the acceptance criteria and performance as presented for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the comparison to a predicate device and compliance with established safety and performance standards. The "performance" in this context refers to the device's technical specifications matching or being acceptably different from the predicate, and its compliance with safety standards.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Compliance
General Comparison (Substantial Equivalence)
Product Code	Must be GEX	GEX
Regulation Number	Must be 21 CFR 878.4810	21 CFR 878.4810
Class	Must be Class 2	Class 2
Where used	Must be hospital	hospital
Intended Use	Vaporization, coagulation in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, otorhinolaryngology	Same as predicate device (human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology)
Performance Comparison (Technical Specifications)
Maximum Power	30W	30W
Work Mode	CW Mode (Continuous Mode), P Mode (Multi-Pulse)	Surgery (Single Pulse, Continuous, Multi-Pulse) (SAME, despite different naming convention)
Wavelength	10.6 um	10.6 um
Beam Delivery	7 joint Light guide arm	7 knucklearmkey joints light arm (SAME)
Light Arm Length	Compared to predicate (1.36m)	1.576m (Analysis: "different not affect the therapeutic effect")
Aiming Beam	650nm	630-650nm red diode laser (≤5 mW) (SAME)
Spot Size	Compared to predicate (0.5 mm ±10%)	0.4 mm (Analysis: "only affects the area of treatment, not affect the therapeutic effect")
Pulse Setting	0.1-1000ms	1-1000ms (SAME)
Power Calibration	Period of 1 year	Period of 1 year
Control System	Touch screen, footswitch	Touch screen, footswitch
Laser Operation	Footswitch	Footswitch
Laser Medium/Energy Source	CO2	CO2
Cooling System	Air cooling	Air cooling
Clean Method	70% alcohol	70% medical alcohol (SAME)
Patient Contacted Part	Skin	Skin
Dimension	Compared to predicate (6642125cm without light arm)	52cm40cm125cm (Analysis: "complying with IEC 60601-1, the mechanical performance... accepted")
Weight	Compared to predicate (80 kg)	65Kg (Analysis: "complying with IEC 60601-1, the mechanical performance... accepted")
Power input	AC 110V/60Hz	AC 100-240v~, 50/60Hz (SAME, implying compatibility)
Safety Comparison (Standards Compliance)
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Complied
EMC	Comply with IEC 60601-1-2	Complied
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Complied
Patient Contact Materials	Must be safe	Aluminum (Analysis: "meet the requirements of ISO 10993-1")
Cytotoxicity	Comply with ISO 10993-1	Complied
Sensitization	N/A - Covered by ISO 10993-1 compliance	N/A - Covered by ISO 10993-1 compliance
Irritation	N/A - Covered by ISO 10993-1 compliance	N/A - Covered by ISO 10993-1 compliance

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

Sample Size: Not applicable. This is a physical device submission, not an AI/ML diagnostic or predictive model that uses a "test set" of patient data. The "testing" involved non-clinical performance and safety evaluations of the device itself.
Data Provenance: Not applicable. The "data" are technical specifications and test results from the device manufacturer, not patient data from a specific country or collected retrospectively/prospectively.

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

Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment is based on engineering specifications, safety standards, and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

Not applicable. There is no test set or expert adjudication process for this type of device submission.

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 is not an AI-based device, and therefore no MRMC study was conducted or relevant.

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

Not applicable. This is not an algorithm or software-only device.

7. The type of ground truth used:

Not applicable. The "ground truth" or basis for acceptance in this submission relies on:
- Predicate Device Specifications: The technical and performance characteristics of a previously cleared device (K192528).
- International Standards Compliance: Adherence to recognized medical device safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825, IEC 60601-1-2, ISO 10993 series).
- Non-Clinical Testing: Results of tests performed on the device to confirm its specifications and safety.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no training set for this device.

Summary

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November 25, 2020

Zhuolu Jontelaser Manufacturing 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, BeiJing 102401 China

Re: K202250

Trade/Device Name: Dermatological Carbon Dioxide Laser 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: GEX Dated: August 27, 2020 Received: August 31, 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.

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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 (OS) 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.

For Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202250

Device Name

Dermatological Carbon Dioxide Laser System

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801.109)

| X 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 of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

Date of Preparation 1.
11/24/2020
1. Applicant Name and Address
  Zhuolu Jontelaser Manufacturing Technology Co., Ltd. No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County, Zhangjiakou City, Hebei, China, 072750
Contact Person Information 3. Karen Liu General Manager Tel: +86-13911459627 Fax: +86-10- 57212057 Email: 919309354@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

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Identification of Proposed Device 5.
Trade Name: Dermatological Carbon Dioxide Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): L300 Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Identification of Primary Predicate 6. 510(k) Number: K192528 Product Name: CO2 Laser Therapy Machine Manufacturer: Shangdong Huamei Technology Co., Ltd.
Device Description 7.

1. Indication For Use
  The Dermatological Carbon Dioxide Laser Systems is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Substantially Equivalent (SE) Comparison 9.

Table 1 General Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	GEX	GEX	SAME
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SAME
Class	2	2	SAME
Where used	hospital	hospital	SAME
Intended Use	The Dermatological Carbon Dioxide LaserSystems is used for human tissuevaporization, coagulation in dermatology	The CO2 Laser Therapy Machine is usedfor human tissue vaporization, coagulationin dermatoloty and plastic surgery, general	SAME

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and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	surgery, gynecology, podiatry, dental and otorhinolaryngology.
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Table 2 Performance Comparison

ITEM	Proposed Device	Predicate Device	Remark
Maximum Power	30W	30W	SAME
work mode	CW Mode (Continuous Mode)P Mode (Muti-Pulse)	Surgery (Single Pulse, Continuous, Muti-Pulse)	SAME
Wavelength	10.6 um	10.6 um	SAME
Beam delivery	7 joint Light guide arm	7 knucklearmkey joints light arm	SAME
Light arm	1.576m	1.36m	Analysis
Aiming Beam	650nm	630-650nm red diode laser (≤5 mW)	SAME
Spot size	0.4 mm	0.5 mm (±10%)	Analysis
Pulse Setting	1-1000ms	0.1-1000ms	SAME
Powercalibration	Period of 1 year	Period of 1 year	SAME
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	Air cooling	SAME
Clean Method	70% alcohol	70% medical alcohol	SAME
PatientContacted Part	Skin	Skin	SAME
Dimension	52cm40cm125cm	6642125cm (without light arm)	Analysis
Weight	65Kg	80 kg	Analysis
Power input	AC 100-240v~, 50/60Hz	AC 110V/60Hz	SAME

Analysis 1

The proposed device is different in light arm length from the predicate device, the different not affect the therapeutic effect. Therefore, this difference will not affect the substantially equivalency.

Analysis 2

The proposed device is different in Spot Size from the predicate device, Spot size only affects the

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area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the substantially equivalency.

Analysis 3

The proposed device is different in dimension and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.

Table 3 Safety Comparison

Item	Proposed Device	Predicate Device	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
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Aluminum	/	Analysis
Cytotoxicity	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Sensitization
Irritation

Analysis

Although the materials in contact with human skin are different, they all meet the requirements of ISO 10993-1 and will not affect product safety.

10. 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 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
IEC 60601-2-22:2007, 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

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safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.

ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
Software Validation & Verification Test
1. Clinical Testing

No clinical study is included in this submission.

1. 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.