(55 days)
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Diode Laser Hair Removal 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 two models included, EVOLUTION MEDICAL, M-I-X MEDICAL, the two 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/cm²), M-I-X MEDICAL (1-70 J/cm²).
The provided text describes a 510(k) premarket notification for a Diode Laser Hair Removal Device, which means the submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information typically associated with complex clinical studies and detailed acceptance criteria for AI/Software as a Medical Device (SaMD) is not present in this document.
However, I can extract the non-clinical acceptance criteria and the studies that verify them, as outlined in the document. The device in question is a physical laser device, not an AI-driven one, so many of the requested categories (like MRMC studies, ground truth for training data, etc.) are not applicable here.
Here's a breakdown of the available information regarding acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)2012 (Consolidated Text) | "Comply with ANSI/AAMI ES60601-1, IEC 60601-2-22" (The document states compliance with the Electrical Safety standard for the proposed device, aligning with the predicate device's compliance.) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | "Comply with IEC 60601-1-2" (The document states compliance with the EMC standard for the proposed device, aligning with the predicate device's compliance.) |
| Laser Safety | IEC 60601-2-22 Edition 3.1 2012-10, IEC 60825-1:2014 | "Comply with IEC 60601-2-22, IEC 60825" (The document states compliance with Laser Safety standards for the proposed device, aligning with the predicate device's compliance.) |
| Biocompatibility - Cytotoxicity | ISO 10993-5 Third Edition 2009-06-01 | "No Cytotoxicity" (The document states no cytotoxicity for the proposed device, aligning with the predicate device's performance.) |
| Biocompatibility - Sensitization | ISO 10993-10 Third Edition 2010-08-01 | "No evidence of sensitization" (The document states no evidence of sensitization for the proposed device, aligning with the predicate device's performance.) |
| Biocompatibility - Irritation | ISO 10993-10 Third Edition 2010-08-01 | "No evidence of irritation" (The document states no evidence of irritation for the proposed device, aligning with the predicate device's performance.) |
| Energy Output Accuracy | (Implicitly, to meet design specifications) | "Performance Testing for Energy Output Accuracy." (Test was conducted, and implicitly, the device met the required accuracy for its specified fluence ranges: EVOLUTION MEDICAL: 1-77 J/cm²; M-I-X MEDICAL: 1-70 J/cm²). The comparison table highlights that the proposed device's fluence range is 'Similar' to the predicate, and analysis states these differences "will not affect the safety and effectiveness". |
| Software Verification & Validation | "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | "Software Verification and Validation Testing was conducted... and the level of concern was determined to be Moderate for the proposed device." (Implies the software meets the necessary requirements for safety and functionality.) |
2. Sample size used for the test set and the data provenance
This information is not applicable as the document describes a physical laser device, not a diagnostic or AI device with a "test set" in the typical sense of evaluating performance on a dataset of images or clinical cases. The "tests" mentioned are primarily engineering safety and performance tests on the device itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth establishment by clinical experts is relevant for diagnostic or AI systems; for this physical device, compliance is measured against engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in clinical studies or AI evaluations to establish a consensus ground truth from multiple readers/experts. This is not reported for the non-clinical tests of this device.
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
This information is not applicable. This describes a physical laser hair removal device, not an AI software intended to assist human readers. No MRMC study was performed or is relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical laser system, not a standalone algorithm. Its performance is evaluated through its physical output and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the established international standards (e.g., IEC 60601-1, ISO 10993-5) and the design specifications for parameters like energy output accuracy. For biocompatibility, the ground truth is the chemical and biological response observed in standardized tests on the material.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that involves a "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" for this physical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
June 29, 2022
Guangzhou CHUANG ZAO MEI Technology Co., Ltd % Asher No Last Name Provided Regulatory Affairs Manager AskWay Innovative Ltd. 4F, Yuehuayuan Building, 2008 Nanshan Avenue, Nanshan Street Nashan District Shenzhen, Guangdong 518000 China
Re: K221312
Trade/Device Name: Diode Laser Hair Removal Device 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 29, 2022 Received: May 5, 2022
Dear Asher No Last Name Provided:
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 and Part 809); 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 (QS) 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,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221312
Device Name Diode Laser Hair Removal Device
Indications for Use (Describe)
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains a logo for "PROF BEAUTY". To the left of the text is a circular graphic containing a line drawing of a woman's face. Below the text is the phrase "innovations creating the beauty".
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Guangzhou CHUANG ZAO MEI Technology Co., Ltd. Dehe international A505, No.2, Qixinggang Industrial Road, JUNHE street, Baiyun District, Guangzhou Contact Person: KARPOV ALEKSANDR Position: General Manager Phone: 086-(0) 13147561925 Email: 3152329212@qq.com
Date Prepared: 06/21/2022
II. SUBMISSION CORRESPONDENT
| Primary Contact Person: | Asher |
|---|---|
| Regulatory Affairs Manager | |
| AskWay Innovative Ltd. | |
| Phone: 086-(0) 18925456615 | |
| Email: Asher@cx.cx | |
| Secondary Contact Person: | Albert Ou |
General Manager AskWay Innovative Ltd. Phone: 086-(0) 13751890680 Email: winner_link@126.com
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Image /page/4/Picture/0 description: The image contains the logo for PROF BEAUTY. To the left of the text is a circular graphic of a woman's face. The text to the right of the graphic says PROF BEAUTY in large, bold letters. Below that text is the phrase "Innovations creating the beauty" in a smaller font.
III. PROPOSED DEVICE
| Trade Name: | Diode Laser Hair Removal Device |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Model(s): | EVOLUTION MEDICAL, M-I-X MEDICAL |
| Classification Name: | Laser Surgical Instrument For Use In General And PlasticSurgery And In Dermatology (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |
| Review Panel: | General & Plastic Surgery |
IV. PREDICATE DEVICE
| 510(k) Number: | K210663 |
|---|---|
| Device Name: | Dermatological Diode Laser Systems |
| Manufacturer: | Beijing HuaCheng Taike Technology Co., Ltd. |
The predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION V.
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 two models included, EVOLUTION MEDICAL, M-I-X MEDICAL, the two 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/cm²), M-I-X MEDICAL (1-70 J/cm²).
vi. INDICATIONS FOR USE
The Diode Laser Hair Removal Device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) 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
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number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
vii. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Diode Laser Hair Removal Device (EVOLUTION MEDICAL, M-I-X MEDICAL) is the same or similar to the cleared predicate device.
The Diode Laser Hair Removal Device (EVOLUTION MEDICAL, M-I-X MEDICAL) has same indications for use with the predicate device, and similar technological characteristics such as fluence, laser wavelength, spot size, and pulse duration, etc. with the predicate device. Please refer to the following table for details:
| Item | Proposed DeviceK221312 | Predicate DeviceK210663 | Remark |
|---|---|---|---|
| Device name | Diode Laser Hair Removal Device | Dermatological Diode Laser Systems | / |
| Product model | EVOLUTION MEDICAL/M-I-X MEDICAL | CM01D/CM02D | / |
| K number | K221312 | K210663 | / |
| Product code | GEX | GEX | Same |
| Classificationregulation | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | 2 | 2 | Same |
| Indications for Use | The Diode Laser Hair removal device (Model: EVOLUTION MEDICAL, M-I-X MEDICAL) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Dermatological Diode Laser Systems (Model: CM01D/CM02D) 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. | Same |
| Prescription use ornot | Prescription use | Prescription use | Same |
| Configuration | Main UnitHandpiece | Main UnitHandpiece | Same |
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| Item | Proposed DeviceK221312 | Predicate DeviceK210663 | Remark |
|---|---|---|---|
| Foot Control | Foot Control | Foot Control | Same |
| Principle ofOperation | Diode laser | Diode laser | Same |
| Laser Type | Diode laser | Diode laser | Same |
| Laser Classification | Class IV | Class IV | Same |
| Laser Wavelength | 808 nm | 808 nm | Same |
| Spot size | 12.6mm*20.6mm | CM01D: 10 x 30 mmCM02D: 9 x 12 mm | Similar |
| Fluence | EVOLUTION MEDICAL: 1-77 J/cm²M-I-X MEDICAL: 1-70 J/cm² | CM01D: 5-100 J/cm²CM02D: 3-30 J/cm² | Similar |
| Frequency | 1-10 Hz | CM01D: 1-10 HzCM02D: 1-3 Hz | Same |
| Pulse Duration | 3-320 ms | CM01D: 15-400 msCM02D: 35-400 ms | Similar |
| Power Supply | AC 120V/60 Hz | AC 110V/60Hz | Similar |
| Dimension | 393mm x 430mm x 1130mm | CM01D: 650mm x 650mm x 1230mmCM02D: 252mm x 210mm x 193mm | / |
| Weight | 48kg | CM01D: 75kgCM02D: 3kg | / |
Analysis:
The proposed device is slightly different in spot size, fluence range, pulse duration, power supply, dimension, and weight from the predicate device. Spot size, fluence range, pulse duration can all be covered by predicate device, the differences in power supply, dimension and weight can be accepted by complying with the non-clinical test conducted. Therefore, these differences will not affect the safety and effectiveness, and the proposed device is determined to be the same or similar with predicate device.
| Item | Proposed DeviceK221312 | Predicate DeviceK210663 | Remark |
|---|---|---|---|
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with ANSI/AAMI ES60601-1,IEC 60601-2-22 | Comply with IEC 60601-1,IEC 60601-2-22 | Same |
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Image /page/7/Picture/0 description: The image contains the logo for PROF BEAUTY. To the left of the text is a circular graphic with a line drawing of a face. Below the company name is the tagline "innovations creating the beauty."
| Item | Proposed DeviceK221312 | Predicate DeviceK210663 | Remark |
|---|---|---|---|
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC60825 | Same |
| Patient Direct/Indirect Contact Materials and Biocompatibility | |||
| PatientDirect/IndirectContactMaterials | Tip of Handle (6063 Aluminum& S1 Quartz) | Tip of Handle (6061 Aluminum&Quartz)Device Housing (AcrylonitrileButadiene Styrene) | Same |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No evidence of sensitization | No evidence of sensitization | Same |
| Irritation | No evidence of irritation | No evidence of irritation | Same |
| Biocompatibilitytestingstandards | Comply with ISO 10993-5,ISO 10993-10 | Comply with ISO 10993-5,ISO 10993-10 | Same |
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Image /page/8/Picture/0 description: The image contains the logo for Prof Beauty. The logo consists of a circular graphic to the left of the text "PROF BEAUTY". The graphic is a line drawing of a face inside of a circle. Below the text "PROF BEAUTY" is the text "innovations creating the beauty".
VIII. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was the same or similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)2012 (Consolidated Text), 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 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 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 Energy Output Accuracy.
Software Verification and Validation Testing was conducted per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the level of concern was determined to be Moderate for the proposed device.
IX. CLINICAL TEST CONCLUSION
No clinical study is included in this submission.
CONCLUSIONS X.
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.
§ 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.