(189 days)
No
The summary describes a standard diode laser hair removal device with no mention of AI or ML features. The device description focuses on the laser technology and its application based on skin type and body area, without any indication of intelligent algorithms for treatment planning, optimization, or analysis.
No
The device is described as a hair removal machine for permanent hair reduction, which is generally considered a cosmetic procedure rather than a therapeutic treatment for a disease or medical condition.
No
Explanation: The device is intended for hair removal and permanent hair reduction, which are therapeutic and cosmetic procedures, not diagnostic ones. It does not mention analyzing or diagnosing any medical condition.
No
The device description explicitly states it is a "surgical device" that utilizes a "semiconductor diode as a laser source" and a "laser handpiece," indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal permanent hair reduction on all skin types". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is described as a "surgical device" that utilizes a laser to treat the skin. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to diagnose diseases or conditions.
Therefore, the Diode Laser Hair Removal Machine is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was 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, ISO 10993-5: 2009, ISO 10993-10: 2010.
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, IEC 60601-1-2:2014, IEC 60825-1:2007.
Particular Performance testing: Performance testing was conducted on the device according to the following standard: IEC 60601-2-22:2007+A1: 2012.
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: 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.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
1
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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3
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
5
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
6
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 |
| Regulation | |||
| Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | 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 Diode Laser Hair Removal | ||
| device 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. | SE | ||
| Configuration | Main Unit | ||
| Hand piece | |||
| Foot Control | Main Unit | ||
| Hand piece | |||
| Foot Control | SE | ||
| SE | |||
| SE | |||
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser | |||
| Classification | Class IV | Class IV | SE |
| Laser | |||
| Wavelength | 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/50-60Hz | |
| 2000VA | 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 with | ||
| IEC 60601-1 | |||
| IEC 60601-2-22, | |||
| IEC 60825 | Comply with | ||
| IEC 60601-1 | |||
| IEC 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.
9
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.