The CO2 Laser Therapy Machine is used for human tissue vaporization 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.

Device Description

The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.

The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment.

The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance.

The proposed device includes the following components: Surgery tip, Surgery tip Arm, Touchscreen, Emergency Switch, Key Switch, Goggles for Patient, Goggles for Doctor, Foot Switch.

AI/ML Overview

The provided document is a 510(k) Summary for a CO2 Laser Therapy Machine. It describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document presents a comparison of the proposed device against a predicate device across various parameters. It doesn't explicitly state "acceptance criteria" for each parameter with numeric thresholds, but rather lists characteristics that are considered "Substantially Equivalent (SE)" if they match or are comparable to the predicate. The performance is reported as the proposed device's specifications.

Parameter	Acceptance Criteria (Implied by Predicate)	Reported Device Performance	Remark (as per document)
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
Maximum Power	CFL-10: 12W (±20%), UFL-60: 30W (±20%)	30W	SE
Work Mode	Scanner (half, fast and random), Surgery (CW, repeat and pulse)	Surgery (Single Pulse, Continuous, Muti-Pulse)	SE
Wavelength	10.6 um	10.6 um	SE
Mode Structure	TEM00	TEM00	SE
Beam Delivery	7 knucklearmkey joints light arm	7 knucklearmkey joints light arm	SE
Light Arm	CFL-10: 0.97m, UFL-60: 1.17m	1.32m	Analysis
Aiming Beam	650nm red diode laser (<1mW)	650nm red diode laser (0.5 mW)	SE
Spot Size	0.5mm (±10%)	0.5 mm	SE
Pulse Setting	Single Pulse (10-1000ms), Time On (10-1000ms), Time Off (10-1000ms)	Single Pulse (Pulse 1-999ms), Muti-Pulse (Repeat Time On 1-999 ms, Time Off 1-999 ms)	SE
Continuous Power	CW CFL-10: 0.1-12W, UFL-60: 0.1-30W	0-30W	SE
Power Calibration	Period of 1 year	Period of 1 year	SE
Control System	Touch screen, footswitch	Touch screen, footswitch	SE
Laser Operation	Footswitch	Footswitch	SE
Laser Medium/Energy	CO2	CO2	SE
Cooling System	Air cooling	Air cooling	SE
Clean Method	70% medical alcohol	70% medical alcohol	SE
Patient Contacted	Skin	Skin	SE
Dimensions	Varied by predicate models (e.g., CFL-10: 210 x 600 x 330 mm)	Varied by proposed models (FG 900: 5646112 cm, FG 900-B: 605432cm, FG 900-C: 4642125cm)	SE
Weight	Varied by predicate models (e.g., CFL-10: 20kg)	Varied by proposed models (FG 900: 49 kg, FG 900-B: 28kg, FG 900-C: 43kg)	SE
Power Input	CFL-10: 120 V AC/60Hz, UFL-60: 120 VAC/60Hz	AC 110V/50Hz-60Hz	SE
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

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

The document states: "No clinical study is included in this submission." The evaluation is based on non-clinical tests and comparisons to a predicate device. Therefore, there is no "test set" in the sense of patient data, and no data provenance information for such a set.

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

Not applicable, as no clinical study or test set with patient data was used to establish ground truth.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set with patient data 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. The device is a CO2 Laser Therapy Machine, not an AI-assisted diagnostic device.

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

Not applicable. The device is a medical instrument, not an algorithm. Performance was evaluated through non-clinical testing of the physical device. The device itself is "standalone" in that it performs its intended function without requiring human intervention in that specific function, but it is operated by a human.

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

For the non-clinical tests, the "ground truth" was established by compliance with international standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10) and verification of design specifications such as Spot Size Accuracy and Energy Output Accuracy, and Software Validation & Verification. These standards and specifications serve as the "ground truth" for the device's technical and safety performance.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as this is a physical medical device, not a machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 5, 2016

Beijing Adss Development Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Liyuan Town, Tongzhou District, Beijing, 101121 CN

Re: K161925

Trade/Device Name: CO2 Laser Therapy Machine 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: July 11, 2016 Received: July 13, 2016

Dear Mr. 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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 -A

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) K161925

Device Name CO2 Laser Therapy Machine

Indications for Use (Describe)

The CO2 Laser Therapy Machine 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)
--	-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #7 510(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.

The assigned 510(k) Number: K161925

1. Date of Preparation
  10/03/2016
Sponsor 2.

Beijing ADSS Development Co., Ltd

F6, Xiandao Bldg., Jinyuan Rd. 36, Daxing Economic Development zone, Beijing, China, 102628

Establishment Registration Number: Not yet registered or the Number Contact Person: Gao Yurong Position: sales manager Tel: 86-10-83625120 Fax:86-10-83625121 Email: gyr@adss.com.cn

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: CO2 Laser Therapy Machine Common Name: Powered Laser Surgical Instrument Model(s): FG 900/FG 900-B/FG 900-C

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;

Intended Use:

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

1. Device Description
  The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement.

The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment.

The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance.

The proposed device includes the following components:

Components	Function Description	Applied Model(s)
Surgery tip	Deliver the laser to area to be treated	FG 900/FG 900-B/FG900-C
Surgery tip Arm	Articulated arm for holding of Surgery tip	FG 900/FG 900-B/FG900-C
Touchscreen	The user interface and for controlling of the system	FG 900/FG 900-B/FG900-C
Emergency	Stop the system in case of emergency situation	FG 900/FG 900-B/FG

Table 1 Main Components of Proposed Device

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Switch
Key Switch	Start the system	FG 900/FG 900-B/FG900-C
Goggles forPatient	Protect the eyes of patient	FG 900/FG 900-B/FG900-C
Goggles forDoctor	Protect the eyes of Operator	FG 900/FG 900-B/FG900-C
Foot Switch	Activate the laser emission	FG 900/FG 900-B/FG900-C

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1. Identification of Predicate Device
  510(k) Number: K110434 Product Name: TRIXEL CO2 LASER Manufacturer: BEIJING SYNTECH LASER CO., LTD.

7. 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic 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 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
Performance Testing for Spot Size Accuracy and Energy Output Accuracy. A
A Software Validation & Verification Test
1. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	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 equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	The equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.	SE
ITEM	Proposed Device	Predicate Device	Remark
Maximum Power	30W	CFL-10: 12W (±20%)UFL-60: 30W (±20%)	SE
work mode	Surgery (Single Pulse, Continuous,Muti-Pulse)	Scanner (half, fast and random)Surgery (CW, repeat and pulse)	SE
Wavelength	10.6 um	10.6 um	SE
Mode Structure	TEM00	TEM00	SE
Beam delivery	7 knucklearmkey joints light arm	7 knucklearmkey joints light arm	SE
Light arm	1.32 m	CFL-10: 0.97mUFL-60: 1.17m	Analysis
Aiming Beam	650nm red diode laser (0.5 mW)	650nm red diode laser(<1mW)	SE
Spot size	0.5 mm	0.5mm (±10%)	SE
Pulse Setting	Single Pulse	10-1000ms	Pulse 1-999ms	SE
	Muti-Pulse	Time On 10-1000msTime Off 10-1000ms	Repeat Time On 1-999 msTime Off 1-999 ms	SE
	Continuous	0-30W	CW CFL-10: 0.1-12WUFL-60:0.1-30W	SE
Power calibration	Period of 1 year	Period of 1 year	SE
Control System	Touch screen, footswitch	Touch screen, footswitch	SE
Laser operation	Footswitch	Footswitch	SE
Lasermedium/energysource	CO2	CO2	SE
Cooling System	Air cooling	Air cooling	SE
Clean Method	70% medical alcohol	70% medical alcohol	SE
PatientContacted Part	Skin	Skin	SE
Dimension	FG 900	5646112 cm	CFL-10 Trixel CO2 Laser: 210 x 600x330 (without light arm)	SE
	FG 900-B	605432cm
	FG 900-C	4642125cm	UFL-60 Trixel II CO2 Laser: 1300 x550x 420(without light arm)
Weight	FG 900	49 kg	CFL-10 Trixel CO2 Laser: 20kg	SE
	FG 900-B	28kg	UFL-60 Trixel II CO2 Laser: 40kg
	FG 900-C	43kg
Power input	AC 110V/50Hz-60Hz ;	CFL-10 Trixel CO2 Laser: 120 VAC/60HzUFL-60 Trixel II CO2 Laser: 120VAC/60Hz	SE
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

Table 2 General Comparison

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Table 3 Performance Comparison

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Table 4 Safety Comparison

Analysis

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

10. Substantially Equivalent (SE) 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.