(84 days)
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The subject device IPL Cooling 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 (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
The provided document is a 510(k) summary for an IPL Cooling Hair Removal Device, which does not typically include information on clinical studies with acceptance criteria as would be found for a diagnostic device. The device is for cosmetic hair removal and its substantial equivalence is based on engineering performance tests and comparison to a predicate device, rather than a clinical effectiveness study with human subjects in the same way an AI-driven diagnostic device might be evaluated.
Therefore, many of the requested categories for a clinical effectiveness study are not applicable or not provided in this document. The device is regulated as a Class II laser surgical instrument for use in general and plastic surgery and in dermatology, but it is indicated for over-the-counter use for unwanted body hair removal.
Here's a breakdown of the information that is available or applicable based on the provided text, and what is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, acceptance criteria are generally based on meeting specified engineering and safety standards, and demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|---|
| Biocompatibility Safety | ISO 10993-5 (In Vitro Cytotoxicity) | Passed |
| ISO 10993-10 (Irritation and Skin Sensitization) | Passed | |
| Electrical Safety | IEC 60601-1-2 (EMC) | Passed |
| IEC 60601-1 (Basic Safety and Essential Performance) | Passed | |
| IEC 60601-1-11 (Home Healthcare Environment) | Passed | |
| IEC 60601-2-83 (Home Light Therapy Equipment) | Passed | |
| Eye Safety (Photobiological) | IEC 62471 (Photobiological safety of lamps and lamp systems) | Passed |
| Software V&V | Consistent with Moderate Level of Concern, all requirements met, all hazards mitigated (System Validation Testing) | Demonstrated |
| Technological Characteristics | Comparison to predicate device (K221001) in intended use, mode of action, and operational characteristics | Determined to be substantially equivalent with minor differences not affecting safety/efficacy |
| Energy Density Range | Within range of predicate device: 2.0-4.3 J/cm² (predicate) | Subject device: 2.0-4.0 J/cm² (model dependent) |
| Wavelength Range | Compared to predicate device: 530-1100nm (predicate) | Subject device: 550-1100nm or 590-1100nm (model dependent) |
The study that proves the device meets the acceptance criteria is a set of safety and performance tests conducted in accordance with recognized international standards, along with a comparison of technological characteristics to a legally marketed predicate device (K221001).
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Provided. The document describes engineering and safety testing, not a clinical trial with a "test set" of patient data. The tests are performed on the device itself or on components (e.g., biocompatibility on materials).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. This is not a diagnostic device requiring expert consensus for ground truth on medical images or diagnoses. Compliance with standards is typically assessed by testing laboratories and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. Adjudication methods are relevant for clinical trials or diagnostic accuracy studies, not for device safety and performance testing against engineering standards.
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/Not Provided. This device is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. This is not an algorithmic device in the context of an AI-driven medical device. Its "software" (for moderate level of concern) would be for device control and safety features, not for standalone diagnostic or analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's acceptance is based on compliance with established international safety and performance standards (e.g., ISO for biocompatibility, IEC for electrical and eye safety), and demonstrating substantial equivalence in technological characteristics and intended use to a legally marketed predicate device. For hair removal effectiveness, the substantial equivalence to an already cleared device implies assumed effectiveness, but no specific effectiveness study data is detailed in this summary.
8. The sample size for the training set
- Not Applicable/Not Provided. This is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. As there is no training set mentioned, this question is not applicable.
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December 1, 2022
Shenzhen Siken 3D Technology Development Co., Ltd. % Rain Yip Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address
Re: K222710
Trade/Device Name: IPL Cooling 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: OHT Dated: August 31, 2022 Received: September 8, 2022
Dear Rain Yip:
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.
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
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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 (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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain, with a faint watermark-like design that does not obscure the text.
Jianting Wang, Ph.D. 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) K222710
Device Name
IPL Cooling Hair Removal Device, model(s): SKB-2008, SKB-2128, SKB-2188, SKB-2118
Indications for Use (Describe)
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
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.
Date: 2022-08-31
I. Submitter
Shenzhen Siken 3D Technology Development Co., Ltd. 4th Building,No.33 Left East Avenue,Songgang, Bao'an District, Shenzhen, Guangdong, China Post code: 518105 Tel.: +86 755 2769 7523
Jingquan Liu R&D director Tel .: +86 150 1255 5680 Email: liudirector@siken3d.com
II. Device
Name of Device: IPL Cooling Hair Removal Device Model(s): SKB-2008, SKB-2128, SKB-2188, SKB-2118 Common or Usual Name: Light Based Over-The-Counter For Hair Removal Classification 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: 510(k) number: K221001 Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd. Trade name: IPL Home Use Hair Removal Device, D-1198 Product code: OHT Approval date: May 12, 2022
IV. Device Description
The subject device IPL Cooling 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 (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Cooling Hair Removal 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 its built-in skin
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sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
There are SKB-2008, SKB-2128, SKB-2188, and SKB-2118 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, and wavelength range, also their energy outputs are slight differences, but these parameters are within the predicate device.
V. Indications for Use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
VI. Comparison of Technological Characteristics With the Predicate Device
The subject device IPL Cooling Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device 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 subject device may be found substantially equivalent to its predicate device.
| ComparisonElements | Subject Device | Predicate device K221001 |
|---|---|---|
| K Number | Pending | K221001 |
| Trade name | IPL Cooling Hair RemovalDevice/SKB-2008,SKB-2128,SKB-2188, SKB-2118 | IPL Home Use Hair RemovalDevice/D-1198 |
| Wavelength range | SKB-2008: 590 | 530-1100nm |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Energy density | SKB-2008: 2.2 | 2.0~4.3J/ $cm²$ |
| Spot size | 3 $cm²$ | 2.7 $cm²$ |
| Pulse duration | 10+/-5ms | 5~12ms |
| Pulsing control | Finger switch | Finger switch |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue |
| Indicationfor | IPL Cooling Hair Removal Device | IPL Home Use Hair Removal |
The subject device is compared with the following Predicate Device in terms of intended use, design, specifications, and performance:
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| ComparisonElements | Subject Device | Predicate device K221001 |
|---|---|---|
| use/Intended use | is an over-the-counter device intended for removal of unwanted body hair. | Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. |
| Location for use | OTC | OTC |
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is ABS plastic and performed the biocompatibility evaluation 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, Document issued on Sep. 4, 2020", 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
2) Electrical Safety and Eve Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 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 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
3) Eye Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). 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 was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
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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 IPL Cooling Hair Removal Device is to be concluded substantial equivalent to its 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.