(149 days)
The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There are 4 models included, FG 2000, FG 2000-B, FG 2000-C and FG 2000-D, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration.
The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part, and each particular treat mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
The provided text is related to a 510(k) premarket notification for a Diode Laser Therapy Machine, a device intended for hair removal and permanent hair reduction.
1. Table of acceptance criteria and the reported device performance:
The document describes the device's technical specifications and how they compare to predicate devices, rather than explicit acceptance criteria and performance for clinical outcomes. The "acceptance criteria" here are essentially the standards and safety requirements met, and the "reported device performance" is its adherence to those standards and its technical parameters.
| Acceptance Criteria (Standards/Technical Parameters) | Reported Device Performance (Proposed Device) |
|---|---|
| General | |
| Product Code (GEX) | GEX |
| Regulation Number (21 CFR 878.4810) | 21 CFR 878.4810 |
| Intended Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. |
| Configuration | Main Unit, Handpiece, Foot Control |
| Principle of Operation | Diode Laser |
| Laser Specifications | |
| Laser Type | Diode Laser |
| Laser Classification | Class IV |
| Laser Wavelength | 808 nm |
| Spot Size | 1.44 cm² |
| Fluence | 2-120 J/cm² |
| Frequency | 1-10 Hz |
| Pulse Duration | 9-143 ms (Noted as different from predicate but covered within predicates' range and not affecting SE) |
| Power Supply | AC 110V/50Hz-60Hz |
| Biocompatibility | |
| Patient Contact Materials | Sapphire in handpiece and handpiece tip (Stainless Steel) |
| Cytotoxicity | No Cytotoxicity (Comply with ISO 10993-5) |
| Sensitization | No evidence of sensitization (Comply with ISO 10993-10) |
| Irritation | No evidence of irritation (Comply with ISO 10993-10) |
| Safety and EMC | |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 |
| EMC | Comply with IEC 60601-1-2 |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 |
| Other Performance | |
| Spot Size Accuracy | Performance Testing conducted |
| Energy Output Accuracy | Performance Testing conducted |
2. Sample size used for the test set and the data provenance:
The submission explicitly states: "No clinical study is included in this submission." Therefore, there is no test set or related data provenance from a clinical study to report. The evaluation relies on non-clinical tests and substantial equivalence to predicate devices.
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 requiring expert ground truth was included.
4. Adjudication method for the test set:
Not applicable, as no clinical study or test set was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission states, "No clinical study is 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 hardware-based medical laser system, not an algorithm.
7. The type of ground truth used:
Not applicable for clinical performance. For the non-clinical tests (e.g., biocompatibility guidance, electrical safety, EMC, laser safety), the "ground truth" is defined by the technical standards themselves (e.g., IEC, ISO standards).
8. The sample size for the training set:
Not applicable, as no clinical study or artificial intelligence/machine learning algorithm requiring a training set was used or described.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used or described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
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: K161692 Trade/Device Name: Diode 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: October 13, 2016 Received: October 17, 2016
Dear Ray Wang:
This letter corrects our substantially equivalent letter of November 16, 2016.
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 -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Diode Laser Therapy Machine
Indications for Use (Describe)
The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
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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: __
-
- Date of Preparation
06/07/2016
- Date of Preparation
-
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
- Submission Correspondent 3.
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: +86-10-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Diode Laser Therapy Machine Common Name: Powered Laser Surgical Instrument Model(s): FG 2000/FG 2000-B/FG 2000-C/FG 2000-D
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 Diode Laser Hair Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs
regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
-
- Device Description
The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
- Device Description
There are 4 models included, FG 2000, FG 2000-B, FG 2000-C and FG 2000-D, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:
| Model | FG 2000-B | FG 2000-C | FG 2000-D | FG 2000 |
|---|---|---|---|---|
| Size | 426354cm | 5646110cm | 5959146 cm | 5646112 cm |
| Weight | 30kg | 45kg | 45kg | 49 kg |
| Handpiece | Refer to Fig 16 | Refer to Fig 4 | ||
| Cooler Number | 1 | 2 | 1 | 2 |
The main components of proposed device shown as following:
Table 2 Main Components of Proposed Device
| Components | Function Description | Applied Model(s) |
|---|---|---|
| Handpiece | Deliver the laser to area to be treated | FG 2000/FG 2000-B/FG2000-C/FG 2000-D |
| Touchscreen | The user interface and for controlling of the system | FG 2000/ FG 2000-B/ FG |
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| EmergencySwitch | Stop the system in case of emergency situation | 2000-C/FG 2000-DFG 2000/ FG 2000-B/ FG2000-C/FG 2000-D |
|---|---|---|
| Key Switch | Start the system | FG 2000/ FG 2000-B/ FG2000-C/FG 2000-D |
| Connector | Connection of the device with the handpiece | FG 2000/ FG 2000-B/ FG2000-C/FG 2000-D |
| Indicator Lamp | Indicate current working state of the appliance | FG 2000/ FG 2000-C |
| Foot Switch | Activate the laser emission | FG 2000/ FG 2000-B/ FG2000-C/FG 2000-D |
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part, and each particular treat mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
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-
- Identification of Predicate Device
Predicate 1# 510(k) Number: K141973 Product Name: Diode Laser Hair Removal System Manufacturer: Beijing Anchorfree Technology Co., Ltd
- Identification of Predicate Device
Predicate 2# 510(k) Number: K123483 Product Name: Diode Laser Manufacturer: Beijing Syntech Laser Co., Ltd
-
- 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:
- Non-Clinical Test Conclusion
-
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-2:2007, 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.
-
Clinical Test Conclusion 8.
No clinical study is included in this submission.
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9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| Product Code | GEX | GEX | GEX | SE |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Diode Laser is intended for use in dermatologic and general surgical procedures.The Standard Mode is intended for hair removal, permanent hair reduction.The FHR Mode is intended for hair removal, permanent hair reduction.The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. | SE, withdifference inwording,while theactualindicationsare the same. |
| Configuration | Main UnitHandpieceFoot Control | Main UnitHandpieceFoot Control | Main UnitHandpieceFoot Control | SE |
| Principle ofOperation | Diode Laser | Diode Laser | Diode Laser | SE |
Table 3 General Comparison
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| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm² | 1.44 cm² | 1.2 cm² | SE |
| Fluence | 2-120J/ cm² | 1-120 J/cm² | 1-120 J/cm² | SE |
| Frequency | 1-10Hz | 1Hz, 2Hz, 3Hz,10Hz | ≤10 Hz | SE |
| Pulse Duration | 9-143ms | 2.9-348ms | 5-200 ms | Discussion 1 |
| Power Supply | AC 110V/50Hz-60Hz | AC220V, 50Hz/ AC110V, 60Hz | 100-240 V 50/60Hz | SE |
| Dimension | 5646112 cm426354cm5646110cm5959146 cm | 380mm×540mm×1200mm | 460X 365 X350 mm | Discussion 2 |
| Weight | 49 kg30kg45kg45kg | 55kg | 25 kg | Discussion 2 |
| Table 4 Performance Comparison | |
|---|---|
Discussion 1
The proposed device is different in Pulse Duration of HR mode from the proposed devices' pulse duration range is cover the predicates' and both proposed device and predicate has same Fluence, this difference will not affect the substantially equivalency.
Discussion 2
The proposed device is different in dimension and weight from the proposed device is a trolley type, while the predicate device is a desktop type. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.
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| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Patient Contact Materials and Biocompatibility | |||
| Patient ContactMaterials | Sapphire in handpiece and handpiece tip(Stainless Steel) | Stainless steel and Sapphire in handpiece | SE |
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | |
| Sensitization | No evidence of sensitization | SE | |
| Irritation | No evidence of irritation | ||
| 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 5 Safety Comparison | |
|---|---|
| --------------------------- | -- |
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.
§ 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.