CO2 Laser Therapy Machine

• K Number: K161925
• Device Name: CO2 Laser Therapy Machine
• Manufacturer: Beijing ADSS Development Co., Ltd
• Date Cleared: 2016-10-05 ( 84 days)
• Product Code: GEX
• Regulation Number: 878.4810

Intended Use

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.

Predicate Devices

K110434

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard CO2 laser therapy machine and its components, focusing on its physical operation and compliance with electrical and safety standards. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.

Therapeutic

Yes.
The device is used for vaporizing, coagulating, and carbonizing human tissue in various medical specialties to achieve treatment purposes, including improving skin conditions and stimulating cell regeneration.

Diagnostic

No

The device is used for treatment by vaporizing, coagulating, and carbonizing human tissue, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a surgery tip, arm, touchscreen, switches, goggles, and a foot switch. It also describes the physical mechanism of action (laser light interacting with skin).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The device is used for "human tissue vaporization, coagulation" in various surgical and medical specialties. This describes a direct treatment or surgical procedure performed on the patient's body.
• Device Description: The description focuses on the laser's interaction with skin tissue to cause peeling and stimulate regeneration. This is a physical interaction with the patient's body.
• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.

The CO2 Laser Therapy Machine is a therapeutic device used for surgical and aesthetic procedures, not for diagnostic testing of samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GEX

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: Deliver the laser to area to be treated
• Surgery tip Arm: Articulated arm for holding of Surgery tip
• Touchscreen: The user interface and for controlling of the system
• Emergency Switch: Stop the system in case of emergency situation
• Key Switch: Start the system
• Goggles for Patient: Protect the eyes of patient
• Goggles for Doctor: Protect the eyes of Operator
• Foot Switch: Activate the laser emission

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human tissue / Skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Software Validation & Verification Test

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110434

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax:[phone] Email: [e-mail]

• 3. 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: [phone] Fax: [phone] Email: [e-mail]

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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.

• 5. 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/FG
900-C
Surgery tip Arm	Articulated arm for holding of Surgery tip	FG 900/FG 900-B/FG
900-C
Touchscreen	The user interface and for controlling of the system	FG 900/FG 900-B/FG
900-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/FG
900-C
Goggles for
Patient	Protect the eyes of patient	FG 900/FG 900-B/FG
900-C
Goggles for
Doctor	Protect the eyes of Operator	FG 900/FG 900-B/FG
900-C
Foot Switch	Activate the laser emission	FG 900/FG 900-B/FG
900-C

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• 6. 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
• 8. 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: 0.97m
UFL-60: 1.17m	Analysis
Aiming Beam	650nm red diode laser (0.5 mW)	650nm red diode laser(