← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K161925
# CO2 Laser Therapy Machine (K161925)
_Beijing Adss Development Co., Ltd. · GEX · Oct 5, 2016 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K161925
## Device Facts
- **Applicant:** Beijing Adss Development Co., Ltd.
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Oct 5, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## 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.
## Device Story
CO2 laser system (models FG 900, FG 900-B, FG 900-C) for medical/aesthetic tissue vaporization and coagulation. Device utilizes high-energy 10.6 µm CO2 laser beam to interact with skin water content, causing surface peeling and photothermolysis to stimulate deep cell regeneration. System includes articulated arm with surgery tip, touchscreen interface, footswitch, and emergency stop. Operated by clinicians in hospital settings. Healthcare providers use touchscreen to control laser parameters (single pulse, continuous, multi-pulse modes) and footswitch to activate emission. Aiming beam (650nm red diode) assists targeting. Benefits include treatment of wrinkles, scars, pigmentation, and dilated pores. Safety features include patient/doctor goggles and key switch.
## Clinical Evidence
No clinical data. Bench testing only. Compliance verified against IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/hypersensitivity). Performance testing confirmed spot size and energy output accuracy.
## Technological Characteristics
CO2 laser medium; 10.6 µm wavelength; 30W max power; TEM00 mode structure. 7-knuckle articulated arm beam delivery. Air cooling. Touchscreen interface; footswitch activation. Electrical safety per IEC 60601-1/60601-2-22; EMC per IEC 60601-1-2; Laser safety per IEC 60825. Biocompatible materials per ISO 10993. Sterilization/cleaning via 70% medical alcohol.
## Regulatory 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.
## Predicate Devices
- TRIXEL CO2 LASER ([K110434](/device/K110434.md))
## Submission Summary (Full Text)
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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
- 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: +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.
- 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(<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 10-1000ms
Time Off 10-1000ms | Repeat Time On 1-999 ms
Time Off 1-999 ms | SE |
| | Continuous | 0-30W | CW CFL-10: 0.1-12W
UFL-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 | |
| Laser
medium/energy
source | CO2 | CO2 | SE | |
| Cooling System | Air cooling | Air cooling | SE | |
| Clean Method | 70% medical alcohol | 70% medical alcohol | SE | |
| Patient
Contacted Part | Skin | Skin | SE | |
| Dimension | FG 900 | 56*46*112 cm | CFL-10 Trixel CO2 Laser: 210 x 600x
330 (without light arm) | SE |
| | FG 900-B | 60*54*32cm | | |
| | FG 900-C | 46*42*125cm | UFL-60 Trixel II CO2 Laser: 1300 x
550x 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 V
AC/60Hz
UFL-60 Trixel II CO2 Laser: 120
VAC/60Hz | SE | |
| Item | Proposed Device | Predicate Device | Remark | |
| EMC, Electrical and Laser Safety | | | | |
| 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 | |
# 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.
---
**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K161925](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K161925)
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