(189 days)
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Hair Removal Machine, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
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); in addition, the treatment can also be applied to different parts of the body.
The provided text is a 510(k) summary for a Diode Laser Hair Removal Machine. This document outlines the rationale for establishing substantial equivalence to a predicate device, focusing on non-clinical performance and safety data rather than a detailed study evaluating specific acceptance criteria for AI performance or clinical outcomes directly.
Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment (especially pertaining to AI/ML device performance or human reader improvement) are not present in this document. This document describes a medical device, but it is not an AI/ML device, and thus the acceptance criteria and study description won't align with questions about AI performance, human-in-the-loop studies, or extensive clinical trials as typically seen for AI-driven diagnostic tools.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the traditional sense of a specific performance threshold (e.g., accuracy > X%). Instead, it demonstrates through non-clinical testing that the device meets safety and performance standards relevant to a laser hair removal machine by comparing it to a predicate device and showing compliance with specific technical standards (e.g., IEC standards, ISO for biocompatibility).
The "performance" is more about compliance with technical specifications and safety standards. The table "Table 1 Comparison of Technology Characteristics" (Page 7) serves as the primary comparison point.
| Item | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Product Code | Same as predicate (GEX) | GEX |
| Regulation Number | Same as predicate (21 CFR 878.4810) | 21 CFR 878.4810 |
| Intended Use | Substantially equivalent to predicate | Intended for hair removal/permanent hair reduction on all skin types (I-VI), including tanned skin, with permanent hair reduction defined as long-term stable reduction measured at 6, 9, 12 months post-treatment. |
| Configuration | Substantially equivalent (Main Unit, Handpiece, Foot Control) | Main Unit, Handpiece, Foot Control |
| Laser Type | Same as predicate (Diode Laser) | Diode Laser |
| Laser Classification | Same as predicate (Class IV) | Class IV |
| Laser Wavelength | Same as predicate (808nm) | 808nm |
| Spot Size | Not raising safety/effectiveness issues despite difference | $12 \times 20mm=2.4cm^2$ (Predicate: $1.44 cm^2$) |
| Power Density (Fluency) | Not affecting substantial equivalence despite difference | 0.96~70J/cm² (Predicate: 1-100J/cm²) |
| Output (Irradiance) | Range covered by predicate | 20.8-208.3W/cm² (Predicate: 14-360W/cm2) |
| Frequency | Range covered by predicate | 1-10Hz (Predicate: 1-20 Hz) |
| Pulse Duration | Range covered by predicate | 50 ~ 400ms (Predicate: 10~400ms) |
| Power Supply | Substantially equivalent | AC110V-240V/50-60Hz (Predicate: AC 110V-230V/50-60Hz) |
| Dimension & Weight | Not raising safety/effectiveness issues despite difference | 460 x 425 x 1120mm, 52Kg (Predicate: 560 x 380 x 1180mm, 60Kg) |
| Patient Contact Material | Biocompatibility tested per ISO 10993 series | Photoconductive crystals (Handpiece), ABS (Handpiece Shell). (Predicate: Sapphire (Handpiece), Unknown (Handpiece Shell)) |
| Biocompatibility (Cytotoxicity) | No Cytotoxicity | No Cytotoxicity |
| Biocompatibility (Sensitization) | No evidence of Sensitization | No evidence of Sensitization |
| Biocompatibility (Irritation) | No evidence of Irritation | No evidence of Irritation |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22, IEC 60825 | Complies |
| EMC | Comply with IEC 60601-1-2 | Complies |
| Accuracy Testing | Energy output and spot size do not deviate tolerance of setting. | Testing conducted, assumed compliance based on no negative findings. |
| Software Verification & Validation | "Major" level of concern. Documentation provided per FDA guidance. | Testing conducted, assumed compliance. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of clinical performance testing for a device like this. The "test set" primarily refers to the device itself and its components undergoing non-clinical bench testing.
- Data provenance: The testing was non-clinical (bench testing, electrical safety, biocompatibility, software V&V). The document does not specify geographic origin for these tests. It states "No clinical study is included in this submission" (Page 6).
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 human reader interpretation for ground truth was performed or required for this 510(k) submission. Ground truth for non-clinical tests would be established by standard measurement equipment and lab protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation or adjudication of medical images/data.
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:
- No, an MRMC study was not done. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this refers to an AI/ML algorithm. This device is a laser hair removal machine, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on engineering specifications, direct measurements of physical properties (e.g., wavelength, power output, dimensions), and established laboratory testing standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). There is no "pathology" or "outcomes data" in this context as no clinical study was conducted.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
April 3, 2020
Beijing Lead Beauty S & T Co., Ltd % Diana Hong General Manager Mid-Link Consultinf Co., Ltd P.O Box 120-119 Shanghai. 200120 CN
Re: K192735
Trade/Device Name: Diode Laser Hair Removal 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: February 24, 2020 Received: March 5, 2020
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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 Hair Removal Machine
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
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Exhibit #4 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:_ K192735
-
- Date of Preparation: 02/07/2020
-
- Sponsor Identification
Beijing Lead Beauty S & T Co., Ltd.
202, No.5 workshop, No.1 caida 3rd Road Nancai Shunyi District, Beijing, China
Establishment Registration Number: Not registered
Contact Person: Jiao Zhang Position: Manager Representative Tel: +86-10-60418096 Fax: +86-10-60418366 Email:13483269828@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Diode Laser Hair Removal Machine Common Name: Laser Hair Removal instrument Model: QDTM-01
Regulatory Information Classification Name: Powered Laser Surgical Instrument; Classification: II; Product Code: GEX: Regulation Number: 21CFR 878.4810; Review Panel: General& Plastic Surgery;
Intended Use Statement:
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Hair Removal Machine, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
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); in addition, the treatment can also be applied to different parts of the body.
5. Identification of Predicate Device
510(k) Number: K180353 Product Name: Diode laser hair removal device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was
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Substantially Equivalent (SE) to the predicate device.
Biocompatibility testing
The biocompatibility evaluation for the Diode Laser Hair Removal Machine was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing including cytotoxicity, Sensitization and Irritation are conducted according to the following standards:
-
ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on Diode Laser Hair Removal Machine. The device complies with the following standards
-
IEC 60601-1: 2005+CORR.1:2006+CORR.2:2007+AMD1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
-
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
-
IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification and requirements.
Particular Performance testing
Performance testing was conducted on the device according to the following standard:
- ♪ IEC 60601-2-22:2007+A1: 2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Software Verification and Validation Testing
The software for this device was considered as a "major" level of concern. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Accuracy Testing
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The accuracy test was conducted to verify that the energy output and spot size of the proposed laser system do not deviate the tolerance of the setting value of energy output or the fixed value of spot size.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K180353 | |||
| Product Code | GEX | GEX | SE |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Hair RemovalMachine is intended for hairremoval permanent hair reductionon all skin types (Fitzpatrick skintype IVI), including tanned skin.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9,and 12 months after thecompletion of a treatment regime. | The Diode Laser Hair Removaldevice is intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin.Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregime. | SE |
| Configuration | Main UnitHand pieceFoot Control | Main UnitHand pieceFoot Control | SESESE |
| Laser Type | Diode Laser | Diode Laser | SE |
| LaserClassification | Class IV | Class IV | SE |
| LaserWavelength | 808nm | 808 nm | SE |
| Spot Size | $12 \times 20mm=2.4cm^2$ | $1.44 cm^2$ | Analysis 1 |
| Power Density | 0.96~70J/cm² | 1-100J/ cm² | Analysis 2 |
| Output | 20.8-208.3W/cm² | 14-360W/cm2 | Analysis 3 |
| Frequency | 1-10Hz | 1-20 Hz | Analysis 4 |
| Pulse Duration | 50 ~ 400ms | 10~400ms | Analysis 5 |
| Power Supply | AC110V-240V/50-60Hz | AC 110V-230V/50-60Hz2000VA | SE |
| Dimension | $460 \times 425 \times 1120mm$ | $560 \times 380 \times 1180mm$ | Analysis 6 |
| Weight | 52Kg | 60Kg | |
| Patient contact material | |||
| Hand peice | photoconductive crystals | Sapphire | Analysis 7 |
| Handpiece Shell | ABS | Unknown | |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SE |
| Sensitization | No evidence of Sensitization | No evidence of sensitization | SE |
| Irritation | No evidence of Irritation | No evidence of irritation | SE |
| Electrical Safety | Comply withIEC 60601-1IEC 60601-2-22,IEC 60825 | Comply withIEC 60601-1IEC 60601-2-22,IEC 60825 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
Table 1 Comparison of Technology Characteristics
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Analysis 1-Spot Size
The spot size of the proposed device is larger than the spot size of the predicate device. Fluency (energy density) is a key factor in laser therapy. The fluency of the proposed device is not much different from the fluency of the predicate device. Therefore, the difference on spot size is considered would not raise any issues in safety and effectiveness. Thus, the proposed device is determined to be substantially equivalency with predicate device.
Analysis 2-Fluence
The fluence for the proposed device is different from predicate device. However, this difference is very slight and electrical safety and EMC test has been conducted on the proposed device and the test result can comply with related standards requirement. Therefore, this difference will not affect substantially equivalence between proposed device and equivalent device.
Analysis 3-Irradiance
The irradiance for the proposed device is different from predicate device. However, the irradiance range for the proposed device can be covered in the range of predicate device. Therefore, this difference will not affect substantially equivalence between proposed device and equivalent device.
Analysis 4-Frequency
The frequency for the proposed device is different from predicate device. However, the frequency range for the proposed device can be covered in the range of predicate device. Therefore, this difference will not affect substantially equivalence between proposed device and equivalent device.
Analysis 5- Pulse Duration
The pulse duration for the proposed device is different from predicate device. However, the pulse duration range for the proposed device can be covered in the range of predicate device. Therefore, this difference will not affect substantially equivalence between proposed device and equivalent device.
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Analysis 6-Dimension and weight
The dimension and weight for the proposed device is different from predicate device. However, the dimension and weight difference is just in physical specification and this difference will not raise any issues in safety and effectiveness. Thus, the proposed device is determined to be substantially equivalency with predicate device.
Analysis 7-Patient Contact Material
The patient contact material for the proposed device is different from predicate device. However, biocompatibility test has been conducted on the proposed device and the test result can meet the requirements of ISO 10993 series standard. Therefore, this difference will not affect substantially equivalence between proposed device and equivalent device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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.