(37 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like training sets, test sets, or specific performance metrics typically associated with AI/ML algorithms. The device description focuses on basic hardware components and safety features.
No
The device is intended for hair removal/reduction, which is a cosmetic purpose and does not treat or prevent a disease or condition.
No
The device is intended for hair removal, a cosmetic function, and does not diagnose any medical condition or disease.
No
The device description clearly outlines physical hardware components such as a Xenon lamp, skin sensor, external power adapter, and finger switch, indicating it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: This device uses Intense Pulsed Light (IPL) to reduce hair growth by acting on the hair follicle within the skin. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the physical removal of unwanted hair, not for diagnosing or monitoring any medical condition.
The information provided clearly describes a physical therapy device for cosmetic purposes, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas with Fitzpatrick Skin Phototypes I-V.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The Home use hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarm and facial hair below the chin line and large areas such as legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use / Over-The-Counter Use
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)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "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 battery of testing was performed to, and passed, including:
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
- Electrical Safety and Eye Safety: Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1 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 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-11 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
- IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- IEC 60601-2-83 Medical Electrical Equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems
- Software Verification and Validation: In this 510(k) submission, the software documentation are the basic documentation. System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Summary: Based on the above performance as documented in this application, the subject device Home use hair removal device was found to have a safety and effectiveness profile that is similar to 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 shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2024
Shenzhen Mlay Intelligent Technology Co., Ltd. Liu Libin General Manager 302,401, Building 1, No. 2, Xiashiwei Road, Huaide Community, Fuyong Street, Baoan District Shenzhen, 518000 China
Re: K240264
Trade/Device Name: Home Use Hair Removal Device (Model(s):T10A, T10C, T10C, T11A, T15A, T17A, T18A, T14A, T16A, T19A) 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: OHT Dated: January 31, 2024 Received: January 31, 2024
Dear Liu Libin:
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 (the 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.
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
1
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 820.30 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 (QS) 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.
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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Tanisha L. Hithe -S 2024.03.08 Hithe -S 12:12:52 -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
3
Indications for Use
510(k) Number (if known) K240264
Device Name
Home Use Hair Removal Device (Model(s):T10A, T10C, T10D, T11A, T15A, T17A, T18A, T16A, T16A, T19A)
Indications for Use (Describe)
The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas with Fitzpatrick Skin Phototypes I-V.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
1. Submitter Information
Shenzhen Mlay Intelligent Technology Co., Ltd. 302,401, Building 1, No. 2, Xiashiwei Road, Huaide Community, Fuyong Street, Ba oan District, Shenzhen, Guangdong, China Post Code: 518000
LIU LIBIN General Manager Tel.: +86 150 6071 0113 Email: amy(@mlays.com
2. Device Information
| Trade name: | Home use hair removal device |
|---|---|
| Model(s): | T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, |
| T14A, T16A, T19A | |
| Common Name: | Light Based Over-The-Counter Hair Removal |
| Regulation Class: | Class II |
| Product Code: | OHT |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21CFR 878.4810 |
| Regulation Description: | Laser surgical instrument for use in general and plastic |
| surgery | |
| Submission Type: | Traditional 510(k) |
3. Predicate Device
| Manufacturer | Predicate Device | 510k Number | Decision Date |
|---|---|---|---|
| Shenzhen Mareal | |||
| Tech Co., Ltd | Home use hair removal | ||
| device, Model(s): T4, T5, | |||
| T8, T4-01, T5-01, T8-01, T7 | K220248 | Jul.01, 2022 |
4. Device Description
The Home use hair removal device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses.
5
5. Indications for Use
The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.
6. Comparison of Technological Characteristics With the Predicate Device
The Home use hair removal device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the Home use hair removal device may be found substantially equivalent to its predicate device.
Home use hair removal device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
| Comparison
| Elements | Subject Device | Predicate Device K220248 |
|---|---|---|
| K Number | Pending | K220248 |
| Trade name | Home use hair removal device, | |
| Model(s): T10A, T10B, T10C, | ||
| T10D, T11A, T15A, T17A, | ||
| T18A, T14A, T16A, T19A | Home use hair removal device, | |
| Model(s): T4, T5, T8, T4-01, | ||
| T5-01, T8-01, T7 | ||
| Location | ||
| for | ||
| use | OTC | OTC |
| Wavelength | ||
| range | 510~1200nm | 530-1100nm |
| Energy | ||
| medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Light Source | Intense Pulsed Light | Intense Pulsed Light |
| Pulsing control | Finger switch | Finger switch |
| Delivery | ||
| device | Direct illumination tissue | Direct illumination tissue |
| Energy density | 1.37~5.23J/cm² | 2.0~4.3J/cm² |
| Spot size | 3.5cm², 3.9cm² | 3.5cm², 3.9cm² |
| Pulse duration | 0.5~8.0ms | 5.0~9.6ms |
| Indication | ||
| for | ||
| use | ||
| intended use | The Home use hair removal | |
| device is an over-the-counter | ||
| device intended for removal of | ||
| unwanted hair such as but not | ||
| limited to small areas such as | ||
| underarm and facial hair below | The Home use hair removal | |
| device is an over-the-counter | ||
| device intended for removal of | ||
| unwanted hair such as but not | ||
| limited to small areas such as | ||
| underarm and facial hair below |
6
Shenzhen Mlay Intelligent Technology Co., Ltd. 036 510(k) Summary
| the chin line and large areas
such as legs, in patients with
Fitzpatrick Skin Phototypes I-V. | the chin line and large areas such
as legs, in patients with
Fitzpatrick Skin Phototypes I-V. |
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------- |
|---|
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "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 battery of testing was performed to, and passed, including:
- A ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- A IEC 60601-1 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 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
IEC60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
IEC 60601-1-11 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
-
IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- A IEC 60601-2-83 Medical Electrical Equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
7
3) Eye Safety
- A IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
In this 510(k) submission, the software documentation are the basic documentation . System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Summary
Based on the above performance as documented in this application, the subject device Home use hair removal device was found to have a safety and effectiveness profile that is similar to the predicate device.
8. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device Home use hair removal device is to be concluded substantial equivalent to its predicate devices.