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

Device Description

The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the CO2 Laser Equipment (K212611):

1. Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K192528) through performance and safety comparisons, rather than explicitly stating quantitative "acceptance criteria" for a novel device performance claim. The "acceptance criteria" are implied by the "Remark" column being "SAME" or "SE" (Substantially Equivalent) between the proposed and predicate devices.

Item	Acceptance Criteria (Implied by Predicate)	Reported Device Performance
Product Code	GEX	GEX
Regulation No.	21 CFR 878.4810	21 CFR 878.4810
Class	2	2
Where used	hospital	hospital
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.
Maximum Power	30W	30W
Work mode	Single Pulse, Continuous, Muti-Pulse	Single Pulse Mode, Continuous Pulse Mode, Multi Pulse Mode
Wavelength	10.6 um	10.6 um
Beam delivery	7 knucklearmkey joints light arm	7 joint Light guide arm
Light arm	1.36m	1.36m
Aiming Beam	630-650nm red diode laser (≤5 mW)	650nm/0.5mW
Spot size	0.5 mm	0.5 mm
Pulse Setting	Single Pulse / 0.1ms-1000ms. Multi Pulse. Continuous 1-30W	Single Pulse / 0.1ms-1000ms. Multi Pulse. Continuous 1-30W
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% medical alcohol	70% medical alcohol
Patient Contacted Part	Skin	Skin
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825
Patient Contact Materials	(Predicate did not specify, implied no significant patient contact for material concerns)	No patient contacting components/materials claimed

For dimensions and weight, the proposed device differs but is deemed acceptable by complying with IEC 60601-1, indicating that this difference is not expected to adversely affect safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a premarket notification for a Class II medical device (CO2 Laser Equipment). The submission is based on demonstrating substantial equivalence to a previously cleared predicate device.

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data in the way one would conduct a clinical trial for a novel device performance claim. The key assessment is against technical specifications and safety standards.
Data Provenance: Not applicable for a typical clinical test set. The data provenance relates to the technical specifications, design documents, and results of non-clinical bench testing. The predicate device's prior clearance provides the established safety and effectiveness benchmark. The manufacturer is Beijing Globalipl Development Co., Ltd. (China).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This submission relies on demonstrating adherence to recognized consensus standards and equivalence to a predicate device, not on expert consensus to establish a "ground truth" for a diagnostic or predictive performance.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is needed or included in this submission."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a CO2 Laser Equipment, a physical surgical instrument, not an AI algorithm or software-only device. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (K192528), along with compliance to recognized international safety and performance standards for medical electrical equipment and laser products (e.g., AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). The submission argues that since the proposed device is technologically similar and meets the same or comparable performance standards, it is as safe and effective as the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary

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February 1, 2022

Beijing Globalipl Development 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: K212611

Trade/Device Name: CO2 Laser Equipment 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: January 4, 2022 Received: January 10, 2022

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 (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 mediation-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 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) K212611

Device Name CO2 Laser Equipment

Indications for Use (Describe)

The CO2 Laser Equipment 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)
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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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510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Section 807.92.

The assigned 510(k) Number: K212611

Date of Preparation 1.
1/31/2022
1. Applicant Name and Address

Beijing Globalipl Development Co., Ltd.

No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County, Zhangjiakou City, Hebei, China, 072750

Contact Person Information 3. Liu Jun
QA Manager Tel: +86-15169727366 Fax: +86-10-60212336 Email: register@globalipl.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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1. Identification of Proposed Device Trade Name: CO2 Laser Equipment Common Name: Powered Laser Surgical Instrument Model(s): US800/US800N 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 System Manufacturer: Shangdong Huamei Technology Co., Ltd.

7. Device Description

The CO2 Laser Equipment includes two models US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size. The detailed difference shown as following:

Table 1 The Difference of Models

Item	US800	US800N
Size	480mm540mm1240mm	440mm540mm1020mm

Indication For Use 8.
The CO2 Laser Equipment is used for human tissue vaporization in dermatology and

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plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

1. Substantially Equivalent (SE) Comparison

Table 2 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 CO2 Laser Equipment 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 dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	SAME

Table 3 Performance Comparison

ITEM	Proposed Device	Predicate Device	Remark
Maximum Power	30W	30W	SAME
Work mode	Single Pulse Mode, Continuous PulseMode, Multi Pulse Mode	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	1.36m	1.36m	SAME
Aiming Beam	650nm/0.5mW	630-650nm red diode laser (≤5 mW)	SAME
Spot size	0.5 mm	0.5 mm	SAME
Pulse Setting	Single Pulse /0.1ms-1000ms.Multi PulseContinuous1-30W	Single Pulse /0.1ms-1000ms.Multi PulseContinuous1-30W	SAME
Power calibration	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% medical alcohol	70% medical alcohol	SAME
Patient Contacted Part	Skin	Skin	SAME
Dimension	US800:48x54x124cmUS800N:44x54x102cm	6642125cm (without light arm)	Analysis
Weight	65Kg	80 kg	Analysis
Power input	AC 110V, 50/60Hz	AC 110V/60Hz	SAME

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Analysis

The proposed device is different in dimensions and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the subject device is determined to be acceptable. Therefore, this difference is not likely to adversely affect the safety and effectiveness of the subject device in comparison to the predicate device.

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	No patient contactingcomponents/materials claimed	/	Analysis

Table 4 Safety Comparison

10. Non-Clinical Testing

Non clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:

A AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety And Essential Performance;
IEC 60601-2-22:2007+A1:2012, 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
Bench Testing to verify the performance
1. Clinical Testing

No clinical study is needed or included in this submission.

1. Conclusion

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The conclusion drawn from the nonclinical tests demonstrates that the subject device CO2 Laser Equipment (US800/US800N) is substantially equivalent to the legally marketed predicate device K192528.

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.