(90 days)
The Diode Laser System is intended for 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 System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Control Panel
b. Main Control Module
c. Constant current board module
d. Temperature and humidity control system
e. Handpiece module
The provided document is a 510(k) Summary for a Diode Laser System intended for hair reduction. It does not contain information about specific acceptance criteria for device performance beyond general safety and effectiveness. The document states "No clinical study is included in this submission." Therefore, the requested information regarding acceptance criteria, device performance, study details, expert involvement, and ground truth cannot be fully provided from the text.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for hair reduction. Instead, it defines the intended use based on "permanent hair reduction... 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."
Performance is primarily addressed through non-clinical tests comparing the proposed device's specifications and safety compliance to predicate devices.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Proposed Device) |
|---|---|
| Safe and effective for permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. | "Diode Laser System is intended for 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." |
| Compliance with relevant electrical safety, EMC, and laser safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). | Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. |
| Biocompatibility of patient-contacting materials (no cytotoxicity, no sensitization, no irritation). | Patient contact materials (Sapphire and aluminum alloy) passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization), showing "No Cytotoxicity," and "No evidence of sensitization" or "irritation." |
| Performance of key parameters (Laser Type, Wavelength, Power Supply) comparable to predicate devices. | Diode Laser, 808 nm wavelength, 100-240V~ 50/60Hz power supply. These are within ranges or similar to predicate devices. |
| Acceptable safety and effectiveness for Fluence and Pulse Duration despite differences from some predicates. | Fluence: 5-40 J/cm². Argued as having "acceptable safety" (lower max than some predicates) and "capable to achieve it's indication for use" (higher max than some predicates). Pulse Duration: 30ms-200ms. Argued as having "acceptable safety" (longer or same as some predicates) and "capable to achieve it's indication for use" (similar to some predicates). |
| Spot Size within ranges found in predicate devices. | 1.20cm² |
| Frequency within ranges found in predicate devices. | 1-5Hz |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no clinical test set, sample size, or data provenance information. Non-clinical tests were conducted to verify design specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical study or test set for efficacy was conducted or provided in this submission for hair reduction. Safety and technical compliance were assessed through non-clinical testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study or test set for efficacy was conducted.
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. This device is a laser system for hair reduction, not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of a physical medical device (Diode Laser System) for hair removal. The "algorithm" in this context refers to the device's control logic, which determines energy output, pulse duration, and frequency. The device operates in a standalone manner in the sense that it mechanically delivers laser energy based on programmed parameters, but its application requires a human operator for treatment and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the primary indication (hair reduction efficacy), no clinical study was presented to establish ground truth from patient outcomes data. The submission relies on substantial equivalence to predicate devices that have established their effectiveness and safety for permanent hair reduction.
For safety (biocompatibility, electrical, EMC, laser safety), the "ground truth" is compliance with recognized international standards (e.g., IEC 60601 series, ISO 10993 series).
8. The sample size for the training set
Not applicable, as no machine learning algorithm requiring a "training set" is mentioned or implied for the intended use and performance assessment described.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
July 16, 2018
Guangzhou Huafei Tongda Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, Xi Yue Hui, No.5, Yi He North Rd. Fang Shan District Beijing, 102401 Cn
Re: K181019
Trade/Device Name: Diode Laser System 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: April 13, 2018 Received: April 17, 2018
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 (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, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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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.
Also, please note the regulation entiled, "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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -53 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) K181019
Device Name
Diode Laser System
Indications for Use (Describe)
The Diode Laser System is intended for 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.
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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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: K181019
-
- Date of Preparation
06/19/2018
- Date of Preparation
-
Sponsor 2.
Guangzhou Huafei Tongda Technology Co., Ltd.
4/F, Building B Industrial and Commercial Trading Park, Hainan Town, Huadi Dadao Nan Road, Fangcun, Liwan District, Guangzhou 510388, P.R. China
Contact Person: Liu Pengqi Position: General Manager Tel: +86-13302285919 Fax: +86-20-81653065 Email: 179330082@qq.com
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Diode Laser System Common Name: Powered Laser Surgical Instrument Model(s): HF-108
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 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.
5. Device Description
The proposed device, Diode Laser System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.
c. Constant current board module
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The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.
d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.
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6. Identification of Predicate Device
510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd.
510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Co., Ltd.
510(k) Number: K112031 Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with Family of Soprano XL Multi-Application Platforms Manufacturer: Alma Lasers, Inc.
510(k) Number: K153718 Product Name: Spirit Hair Removal Laser Family. Spirit-918/cFactor -918/mFactor-918 Manufacturer: Active Optical Systems 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:
- A IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance:
-
IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
-
IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
-
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
-
- Clinical Test Conclusion
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No clinical study is included in this submission.
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9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate DeviceK162659 | Predicate DeviceK142845 | Predicate DeviceK112031 | Predicate DeviceK153718 | Remark |
|---|---|---|---|---|---|---|
| Product Code | GEX | GEX | OHT | GEX | GEX | SE |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser System isintended for hair removal,permanent hair reduction onall skin types (Fitzpatrickskin type I-VI), includingtanned skin.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime. | The Diode Laser System isintended for hair removal,permanent hair reduction onall skin types (Fitzpatrick skintype I-VI), including tannedskin.Permanent hair reduction isdefined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime. | The SILKPRO is anover-the-counter device intendedfor adjunctive use with shavingfor hair removal sustained withperiodic treatments. SILKPRO isalso intended for permanentreduction in hair regrowthdefined as a long-term, stablereduction in hair countsfollowing a treatment regime.permanent hair reduction isdefined as long term, stablereduction in the number of hairsregrowing when measured out to6, 9, and 12 months after thecompletion of the treatmentregimen | The Alma Lasers Family of SopranoXL Multi-Application Platforms isintended for use in dermatologic andgeneral surgical procedures.The Alma Lasers Modified DiodeLaser Module (used with AlmaLasers Family of Soprano XLMulti-Application Platforms):The HR modes is intended for hairremoval, permanent hair reduction.The SHR Mode is intended for hairremoval, permanent hair reduction.The LaserBlanche Mode is intendedfor the treatment of benign vascularand pigmented lesions.The Alma Lasers Family of SopranoXL Multi-Application Platforms isintended for use on all skin types | The Spirit Hair Removal LaserFamily is generally intended fordermatological use. The devices arespecifically indicated for hairremoval, permanent hair reductionby using selective laser energy.The Spirit Hair Removal LaserFamily is intended for use on allskin types (Fitzpatrick skin typesI-VI), including tannedskin.Permanent reduction in hairregrowth is defined as long term,stable reduction in the number ofhairs regrowing when measured outto 6, 9, and 12 months after thecompletion of the treatment regimen. | SE |
Table 7-1 General Comparison
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| (Fitzpatrick skin types I-VI),including tanned skin. | ||||||
|---|---|---|---|---|---|---|
| Main Unit | Main Unit | / | Main Unit | / | SE | |
| Configuration | Handpiece | Handpiece | Handpiece | Handpiece | Handpiece | SE |
| Foot Control | Foot Control | / | Foot Control | / | SE | |
| Principle ofOperation | Diode Laser | Diode Laser | Diode Laser | Diode Laser | Diode Laser | SE |
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| Item | Proposed Device | Predicate DeviceK162659 | Predicate DeviceK142845 | Predicate DeviceK112031 | Predicate DeviceK153718 | Remark |
|---|---|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser | Diode Laser | SE |
| LaserClassification | Class IV | Class IV | Class IV | Class IV | Class IV | SE |
| LaserWavelength | 808 nm | 808 nm | 810 nm | 810 nm | 810 nm | SE |
| Spot Size | 1.20cm² | 1.44 cm² | 9 x 9 mm (0.81 cm²) | 1.20cm² | 12 x 16 mm (1.92 cm²) (Model 918) | Discussion |
| PulseDuration | 30ms-200ms | 5-400ms | / | 5-200ms (HR Mode); ≤ 20ms (SHR Mode) | Up to 310 ms (Model 918) | Discussion |
| Fluence | 5-40 J/cm2 | 1-120J/ cm² | 5 - 25J/ cm2 | 1-120J/ cm² (HR Mode); ≤ 10 J/ cm² (SHR Mode) | 6-90 J/cm² (Model 918) | Discussion |
| Frequency | 1-5Hz | 0.5-15Hz | / | ≤ 3 Hz (HR Mode); ≤ 10 Hz (SHR Mode) | ≤ 10 Hz (Model 918) | Discussion |
| Power Supply | 100-240V~ 50/60Hz | AC 110V/60Hz | / | / | / | Discussion |
| Dimension | 510mm×600mm×1000mm | 450mm×550mm×380mm | / | / | / | Discussion |
| Weight | 50Kg | 52Kg | / | / | / | Discussion |
Table 7-2 Performance Comparison
Discussion
The proposed device has same indication for use with 4 predicate devices, such as spot size, fillerce, frequency range, pulse duration.
For these output parameters, the Fluence and Pulse the parameters which may decides that how much and how long time the energy will deliver to
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510(k) Summary
the patient's skin, it may effects the safety (too long action time) may burn patient's skin, and effectiveness (too low energy and or too short action time) may make the device could not achieve it's indication for use.
From the comparison above, the fluence of proposed device is 5-40 June, the finence of predicate device are 1-1200 cm², They are not exactly same, but the fluence of proposed or limited the fluence of predicate device. Because the maximum fluence of proposed are lover than some predicate device (120 J/cm²), it can be considered as the proposed device has acceptable safety; and the maximum fluence of proposed are higher than some rredicate device (25// on) , 10 J/ cm²) it can be croposed device has capable to achieve it's indication for use. The Pulse duration of proposed device is 30 ms -200 ms, which is similar with the pulse duration of predicate device, which is longer or same than some predicate device (200 ms, 400 ms), and less than some predicate device (20 ms), so same reason as fluence, the pulse device has acceptable safety and has capable to achieve it's indication for use.
As the justification above, the difference of pulse ranges does not affect the safety or effectiveness of proposed device for it's indications for use.
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Table 7-3 Safety Comparison
| Item | Proposed Device | Predicate DeviceK162659 | Predicate DeviceK142845 | Predicate DeviceK112031 | Predicate DeviceK153718 | Remark |
|---|---|---|---|---|---|---|
| Patient Contact Materials and Biocompatibility | ||||||
| Patient ContactMaterials | Sapphire and aluminum alloy inhandpiece | Sapphire in handpiece | Discussion | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | ||||
| Sensitization | No evidence of sensitization | No evidence of sensitization | SE | |||
| Irritation | No evidence of 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, 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, IEC60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |
Discussion
The proposed device is different in Patient Contacte device. but both the predicate device and the proposed device has passed the 1SO 1099 series test, we believe these differences will not affectiveness and safety compared with the predicate is deternined to be substantially equivalency with predicate device.
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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.