(61 days)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device includes 12 models, they are M8011, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of "M80XX" are equipped with cooling function for a better hair remove experience, while those of "M70XX" have no cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.
This FDA 510(k) clearance letter pertains to an IPL Hair Removal Device. The document provided does not detail specific acceptance criteria for a clinical study proving device performance, nor does it describe such a study. Instead, it focuses on non-clinical testing for safety and electrical performance, and a comparison to predicate devices for substantial equivalence.
Therefore, many of the requested sections about clinical study details cannot be answered from the provided text.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance directly related to hair removal efficacy. The "Performance data" mentioned within the "Comparison of Technological Characteristics With the Predicate Device" section refers to safety and electrical performance to support substantial equivalence, not clinical efficacy.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical testing (test set) is described. The non-clinical testing (biocompatibility, electrical safety, etc.) would typically use material samples or test units, not human subjects or "data provenance" in the sense of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical testing requiring expert ground truth is described.
4. Adjudication method for the test set
Not applicable. No clinical testing with adjudication is described.
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
Not applicable. This device is an IPL hair removal device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm; it's a physical device for hair removal.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by validated test methodologies and standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety).
8. The sample size for the training set
Not applicable. No training set is mentioned as there is no AI/machine learning component described for this device.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
Summary of what can be extracted from the document regarding "acceptance criteria" and "study":
The document focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technological characteristics, rather than demonstrating efficacy through a dedicated clinical study with specific performance acceptance criteria.
Non-Clinical Testing:
The following non-clinical standards were followed, and presumably, adherence to these standards constitutes the "acceptance criteria" for these specific aspects of the device:
-
Biocompatibility:
- ISO 10993-5: 2009 (Tests for in vitro cytotoxicity)
- ISO 10993-10: 2021 (Tests for skin sensitization)
- ISO 10993-23: 2021 (Tests for irritation)
- Acceptance Criteria (implicit): The device materials must demonstrate non-cytotoxicity, non-sensitization, and non-irritation as per the requirements of these ISO standards.
- Reported Performance: The document states that differences in materials of patient contact components (compared to the predicate) were "solved by biocompatibility tests," implying the device successfully passed these tests.
-
Electrical Safety and Performance:
- IEC 60601-1:2020 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2020 (Electromagnetic compatibility)
- IEC 60601-1-11:2020 (Home healthcare environment requirements)
- IEC 60601-2-83: 2022 (Home light therapy equipment particular requirements)
- IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
- IEC 60601-1-6: 2020 (Usability)
- Acceptance Criteria (implicit): The device must comply with all relevant clauses and performance limits specified in these IEC standards for electrical safety, electromagnetic compatibility, home use, specific light therapy equipment risks, photobiological safety, and usability.
- Reported Performance: The document provides "performance data were provided in support of the substantial equivalence determination" by listing these standards, indicating successful adherence.
Regarding Clinical Testing:
The document explicitly states: "Clinical Testing: Not applicable." This means no clinical study was conducted, or deemed necessary by the FDA, to demonstrate the device's efficacy for hair removal as part of this 510(k) submission process. Its efficacy is likely presumed based on the established science of IPL technology and the substantial equivalence to already cleared predicate devices for the same intended use.
U.S. Food & Drug Administration FDA 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
March 19, 2025
Mustech Electronics Co., Limited
℅ Riley Chen
Registration Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90
Qianhai Road
Shenzhen, Guangdong 518052
China
Re: K250131
Trade/Device Name: IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
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 17, 2025
Received: January 17, 2025
Dear Riley Chen:
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 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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K250131 - Riley Chen
Page 2
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 (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-reporting-combination-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.
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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K250131 - Riley Chen
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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,
YAN FU -S Digitally signed by YAN FU -S
Date: 2025.03.19 12:42:24
-04'00'
for 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
Page 4
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known)
K250131
Device Name
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
Indications for Use (Describe)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Mustech Electronics Co., Limited
K250131 – 510(k) Summary
Page 1 of 4
510(k) Summary #K250131
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Mustech Electronics Co., Limited
Address: 3F, Building No.B2, Shanghe industry Park, NanChang Road, Xixiang Town, Baoan District, Shenzhen, Guangdong, China
Post code: 518126
Fax: +86-0755-27670391
Kevin Liu
Title: Project Supervisor
Tel.: +86-0755-27967595-808
Email: kevin@mustech.com
Date of preparation: 2025-01-13
II. Device
Name of Device: IPL Hair Removal Device
Model(s): M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023
Common or Usual Name: Light Based Over-The-Counter Hair Removal
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHT
Regulation Number: 21 CFR 878.4810
III. Predicate Device
| Predicate Device | Manufacturer | 510(k) Number | Product code |
|---|---|---|---|
| Hair Removal Device (R2815-G Pro, R2815-G) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | K232575 | OHT |
| Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science and Technology Co., Ltd | K223928 | OHT |
IV. Device Description
IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain.
The device includes 12 models, they are M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of "M80XX" are equipped
Page 6
Mustech Electronics Co., Limited
K250131 – 510(k) Summary
Page 2 of 4
with cooling function for a better hair remove experience, while those of "M70XX" have no cooling function.
The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.
V. Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Comparison of Indications for Use: The indications for use of the subject device is comparable to the indications for use of the predicate devices.
VI. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same indications for 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 devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
IPL Hair Removal Device is compared with the following predicate devices in terms of intended use, design, specifications and performance:
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| 510(k) Number | Pending | K232575 | K223928 | / |
| Trade name | IPL Hair Removal Device | Hair Removal Device | Intense Pulsed Light (IPL) System | / |
| Model | M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023 | R2815-G Pro, R2815-G | T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | / |
| Indication for use/ Intended use | IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair. | Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair. | The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair. | Same |
| Prescription or OTC | OTC | OTC | OTC | Same |
| Design | Hand-held | Hand-held | Hand-held | Same |
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Mustech Electronics Co., Limited
K250131 – 510(k) Summary
Page 3 of 4
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Power source | An external power adapter | An external power supply | An external power supply | Same |
| Power supply | 100-240V, 50/60Hz | 100~240V, 50/60Hz | / | Same |
| Dimensions | M7011, M7012, M8011, M8012, M8013, M8015: 179mm x 65mm x 39mm M7021, M7023, M8021, M8022, M8023, M8025: 180mm x 71mm x 39mm | 19411745mm | 9044225mm for T016K | Different |
| Sterilization | Not required | Not required | Not required | Same |
| Light source | Intense Pulsed Light (IPL) | Intense Pulsed Light (IPL) | Intense Pulsed Light (IPL) | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength range | 530nm-1200nm | 530-1200nm | 510nm~1200nm | Same |
| Energy density | M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025: 1.8 | Max. 5.2J/cm2 (range in 1.2J/cm2~5.2J/cm2) | Max. 5.73J/cm2 for T016K | Similar |
| Output energy | M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025: 6.0 | 5~14.5J | 4.8J~18.9J for T016K | Similar |
| Spot size | M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025: 3.4 cm² M7011, M7012, M7021, M7023: 3.3cm2 | 3.4±0.25 cm² | 3.3cm2 for T016K | Same |
| Pulse duration | 8.2~11.0ms | 8.5±2.5ms (range in 6ms~11ms) | 4 ~ 12ms | Similar |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Software/ Firmware/ Microprocessor Control? | Yes | Yes | Yes | Same |
Page 8
Mustech Electronics Co., Limited
K250131 – 510(k) Summary
Page 4 of 4
| Comparison Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| Material of Patient contact components | ABS+PC, Sapphire (Al2O3), Reflective cover bracket (POM), Silicone stopper (Silica gel) | PC+ABS, Sapphire (Al2O3), Stainless steel 430 | T016K: PC for button, PC for main housing and Probe cover, Sapphire Crystal Cooling Compress | Different, but solved by biocompatibility tests |
VII. Non-Clinical Testing
The following performance data were provided in support of the substantial equivalence determination.
- ISO 10993-5: 2009, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23: 2021, Biological evaluation of medical devices - Part 23: Tests for irritation
- IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- IEC 60601-1-11:2020, Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance –Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-83: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471: 2006, Photobiological safety of lamps and lamp systems
- IEC 60601-1-6: 2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
VIII. Clinical Testing
Not applicable.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed 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.