(90 days)
Not Found
No
The summary describes a standard diode laser hair removal device with remote data access and upgrade capabilities. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for treatment planning, parameter adjustment, or outcome prediction. The changes mentioned are related to data management and remote updates, not intelligent processing.
Yes
The "Summary of Performance Studies" section mentions adherence to "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," which explicitly includes "Therapeutic" in its title. While the primary stated use is hair removal, the device is a laser intended for medical procedures and is designed to alter biological function of the tissue by reducing hair growth, which can be considered a therapeutic effect for some conditions.
No.
The device is intended for hair removal and permanent hair reduction, which are therapeutic and cosmetic applications, not diagnostic.
No
The device is a physical laser hair removal device with hardware components (diode laser, handpiece, foot switch) and associated software for control and data management. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "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 device used for a physical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 J/cm^2), M-I-X MEDICAL (1-70 J/cm^2), Lotus(1-67 J/cm^2), and Ultimate(1-65 J/ cm^2).
Changes to the device include the addition of a remote link to the device to obtain and back up the device’s usage data, a remote upgrade function, and the ability to provide a URL for users to download the device’s usage data, as compared to previously listed devices.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
ANS//AAM ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)].
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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.
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitto Cytotoxicity).
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility).
IEEE ANSI USEMCSC C63.27-2021, American National Standard for Evaluation of Wireless Coexistence.
AAM TIR69:2017/(R2020), Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
Cybersecurity Testing was conducted per the latest FDA Guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023.
Performance Testing for Energy Output Accuracy.
Software Verification and Validation Testing was conducted per the latest FDA Guidance titled "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, and the level of concern was determined to be Moderate for the proposed device.
Conclusion: Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2025
Guangzhou CHUANG ZAO MEI Technology Co., Ltd. % Asher William Regulatory Affairs Manager AskWay Innovative Ltd. 4F, Yuehuayuan Building, 2008 Nanshan Avenue Nanshan Street Nashan District Shenzhen, 518000 China
Re: K243465
Trade/Device Name: Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate) 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: November 8, 2024 Received: November 8, 2024
Dear Asher William:
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 (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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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,
Digitally signed by TANISHA L. TANISHA L. HITHE -S Date: 2025.02.06 HITHE -S 22:01:16 -05'00'
Tanisha Hithe 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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Indications for Use
510(k) Number (if known) K243465
Device Name
Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS): Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
Indications for Use (Describe)
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus and Ultimate) 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.
| 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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| 510(k) #: | 510(k) Summary | Prepared on: 2025-02-06 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Guangzhou CHUANG ZAO MEI Technology Co.,Ltd. | |||
| Applicant Address | Dehe international A505,No.2,Qixinggang Industrial Road, JUNHE street,Baiyun District Guangzhou Guangdong 510440 China | |||
| Applicant Contact Telephone | 13242057537 | |||
| Applicant Contact | Mr. SERGEI SLASHCHILIN | |||
| Applicant Contact Email | info@icbtech.pro | |||
| Correspondent Name | AskWay Innovative Ltd. | |||
| Correspondent Address | 4F, Yuehuayuan Building, 2008 Nanshan Avenue, Nanshan Street Nashan District Shenzhen CN 518000 China | |||
| Correspondent Contact Telephone | 13342086538 | |||
| Correspondent Contact | Mr. Asher William | |||
| Correspondent Contact Email | Asher@cx.cx | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); | |||
| Diode Laser Hair Removal Device (M-I-X MEDICAL); | ||||
| Diode Laser Hair Removal Device (GENESIS); | ||||
| Diode Laser Hair Removal Device (Lotus); | ||||
| Diode Laser Hair Removal Device (Ultimate) | ||||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | |||
| Classification Name | Powered Laser Surgical Instrument | |||
| Regulation Number | 878.4810 | |||
| Product Code(s) | GEX | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | K221312 | Predicate Trade Name (Primary Predicate is listed first) | Diode Laser Hair Removal Device | Product Code |
| GEX | ||||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The Diode Laser Hair Removal Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode laser as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot switch and a laser handpiece. There are five models included, EVOLUTION MEDICAL, M-I-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same |
There are five models included, EVOLUTION MEDICAL, M-X MEDICAL, GENESIS, Lotus, and Ultimate, the five models have same
5
mechanism of action, principle and specification, with only one difference: the adjustable range of Energy density is different, EVOLUTION MEDICAL (1-77 //cm^2), M-FX MEDICAL (1-70 //cm^2), Lotus(1-67 //cm^2), and Ultimate(1-65 J/ cm^2).
Changes to the device include the addition of a remote link to the device to obtain and back up the device's usage data, a remote upgrade function, and the ability to provide a URL for users to download the device's usage data, as compared to previously listed devices.
Intended Use/Indications for Use
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, GENESIS, Lotus and Ultimate) 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.
Indications for Use Comparison
The Diode Laser Hair Removal Device (EVOLUTION MEDICAL, GENESIS, Lotus, and Ultimate) has same indications for use with the predicate device.
Technological Comparison
The Diode Laser Hair Removal Device (EVOLUTION MEDICAL, GENESIS, Lotus, and Ultimate) models have the same laser treatment output wavelength of 808 nm, pulsewidth range of 3-320 milliseconds, and repetition rate range of 1 – 10 Hz, as the predicate device models (EVOLUTION MEDICAL). The treatment window size of 12 millimeters (mm) X 18 mm for the proposed models in this 510(k) is smaller than the predicate device's 12.6 mm X 20.06 mm. The proposed models have the following fluence ranges: EVOLUTION MEDICA: 1-77 J/cm2, M-IX MEDICAL: 1-70 J/cm2, GENESIS: 1-74 J/cm2, Ultimate: 1-65 J/cm2, while the predicate models have the following fluence ranges: EVOLUTION MEDICAL: 1-77 J/cm2, M-I-X MEDICAL: 1-70 J/cm2. The proposed device also includes wireless connectivity to a computer server to store device settings and to allow for software upgrades. The proposed device models' fluence ranges, the change in treatment window size, and the proposed device's additional wireless connectivity, are considered to be acceptable with regard to the proposed device's safety and efficacy for the proposed indications for use.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
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:
ANS//AAM ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)].
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
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.
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitto Cytotoxicity).
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Biocompatibility).
IEEE ANSI USEMCSC C63.27-2021, American National Standard for Evaluation of Wireless Coexistence.
AAM TIR69:2017/(R2020), Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
Cybersecurity Testing was conducted per the latest FDA Guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
6
Performance Testing for Energy Output Accuracy.
Software Verification and Validation Testing was conducted per thelatest FDA Guidance titled "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, and the level of concern was determined to be Moderate for the proposed device.
Conclusion:
Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the predicate device.