Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology plastic surgery and general surgery.

Device Description

Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.

AI/ML Overview

Based on the provided text, the device in question is a "Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)". The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/algorithm performance.

Instead, the document is a 510(k) premarket notification for a medical device (a laser system) and focuses on demonstrating its substantial equivalence to a legally marketed predicate device through non-clinical testing. It explicitly states:

"No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/algorithm performance. The document only discusses the physical and electrical characteristics of the laser device and its general safety and effectiveness in comparison to a predicate device, as required for a 510(k) submission.

The questions you've asked (sample size for test/training sets, data provenance, expert consensus, MRMC studies, standalone algorithm performance) are highly relevant to the evaluation of AI/ML-based medical devices. This document, however, describes a traditional medical device submission for a laser system which does not appear to involve AI/ML components for which such performance criteria would be established and studied.

Summary

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December 20, 2024

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Beijing ADSS 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, 102401 China

Re: K241670

Trade/Device Name: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) 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: November 15, 2024 Received: November 15, 2024

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Digitally signed by YAN FU -S
YAN FU -S Date: 2024.12.20 12:41:15
-05'00'

for Tanisha Hithe 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241670

Device Name

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

Indications for Use (Describe)

Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology plastic surgery and general surgery.

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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K241670 The assigned 510(k) Number:

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.

1. Date of Preparation: 2024.06.04
1. Sponsor Identification

Beijing ADSS Development Co., Ltd.

Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing, 102600, P. R. China

Contact Person: Jijuan Wang Position: IRM Tel: +86- 18519081708 Fax: 86-10-83625121 (EXT. 801) Email: ira@adss.com.cn

1. Designated 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, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: infor@believe-med.com

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1. Identification of Proposed Device
  Trade Name: Fractional CO2 Laser Therapy System

Common Name: Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output

Regulatory Information Classification Name: Powered Laser Surgical Instrument, Powered Laser Surgical Instrument With Microbeam\Fractional Output Classification: II Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery

1. Identification of Predicate Device(s)
  510(k) Number: K221597 Product Name: Co2 Laser System Manufacturer: Smedtrum Medical Technology Co., Ltd.

6. Device Description

7. Indication For Use Statement:

Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology,plastic surgery and general surgery.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device(K221597)	Remark
Manufacturer	Beijing ADSS DevelopmentCo.,Ltd.	Smedtrum Medical TechnologyCo., Ltd.	/
Device Name	Fractional CO2 Laser Therapy System	CO2 Laser System	/
Intended use	Fractional CO2 Laser Therapy Systemis used for body soft tissue ablation,vaporization, excision andcoagulation in dermatology,plasticsurgery and general surgery.	The CO2 Laser System is usedfor body soft tissue ablation,vaporization,excision andcoagulation in dermatology,plastic surgery and generalsurgery.	Same
LaserWavelength	10.6µm	10.6µm	Same
Lasermedium/energysource	CO2	CO2	Same
Max. OutputPower Watts	Max 35W	Max 35W	Same
OperationalMode	Fractional mode, and normal mode(Continuous output , Single pluse,Repetitive pulse )	Fractional mode, and normalmode (CW, Single, Pulse,S-pulse,U- pulse)	Analysis1
Aiming beam	Red diode laser,Max 5mW	< 2 mw /650 nm/Semiconductor Laser LD	Analysis2
Cooling	Air cooling	Forced-air cooling	Same
Beam DeliveryHandpiece	Articulated arm withcounterweight	Articulated arm withcounterweight	Same
Laser firingControls	LCD color TouchscreenFootswitch	LCD color TouchscreenFootswitch	Same
ElectricalRequirements	230V,50/60HZ	110-240VAC,50-60Hz	Analysis3
Fractional Model
Pulse Energy	1-300mj/dot	1-300mj/dot	Same
Spot size	0.12mm	0.12mm	Same
Spot Density(DPA)/ cm2	25, 36, 49, 64, 81, 100, 121, 144, 169, 196, 225, 256, 289, 324, 361, 400,	25, 36, 49, 64, 81, 100, 121, 144, 169, 196, 225, 256, 289, 324, 361, 400	Same

Tab 1 General Comparison

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441, 484, 529, 784, 1024, 1521, 2025,2500, 3025 dots.		361, 400, 441, 484, 529, 784,1024, 1521, 2025, 2500,3025 dots.
Scan Area Size	2x2mm-20x20mm		2x2mm-20x20mm		Same
Normal Model
PulseDuration	Continuousoutput	N/A	CW	N/A	Same
	Singlepulse	1~375 ms	single	1~375 ms	Same
	Repetitivepulse	Pulse width:0.1~375 msDelay time:1-500ms	pulse	Pulse width:5~~375 msDelay time:1~~500 ms	Same
			S-Pulse	Pulse width:1~~4 msDelay time:1~~100 ms
			U-pulse	Pulse width:0.1-0.9 msDelay time:1-100 ms

Analysis

Although the operating modes of proposed device and predicate device are different, the parameters in different operating modes are comparable.Therefore, this difference will not affect safety and effectiveness of the proposed device.
The aiming beam power of proposed device does not cause heat or energy hazard to the patients during the treatment procedure. Therefore, this difference will not affectiveness of the proposed device.
The electrical requirements for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this electrical requirements. Therefore, this difference will not affect safety and effectiveness of the proposed device.

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1. 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:
A IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
♪ IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements

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

ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
A ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation

▲ ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity

IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment-Part 1-2: General A Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Test

Clinical Test Conclusion 10.

No clinical study is included in this submission.

11. Conclusion

Based on the nonclinical tests performed , the subject device is as safe, as effective, and performance as well as the legally marketed predicate device, CO2 Laser System cleared under K221597.

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.