(60 days)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.
IPL Hair Removal Device (Model: KCA423, KCA437, KCA439), is an over-the-counter, homeuse and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). 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. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only user with suitable skin tone can use this device.
Based on the provided FDA 510(k) summary, here's an analysis of the acceptance criteria and the study proving the device meets them:
The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing against recognized standards rather than setting specific acceptance criteria for efficacy in the traditional sense of AI/algorithm performance. The "device" in question is an IPL Hair Removal Device, not an AI or algorithm. Therefore, many of the requested points regarding AI/algorithm-specific studies (like MRMC, standalone algorithm performance, training set details, ground truth establishment methods for algorithms) are not applicable.
The acceptance criteria here are derived from compliance with recognized medical device standards for safety and performance, and the "study" is the collection of tests performed to demonstrate this compliance.
1. A table of acceptance criteria and the reported device performance
Since this is an IPL hair removal device and not an AI/algorithm, "performance" is demonstrated through compliance with safety and performance standards. The acceptance criteria are implicit in meeting these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Compliant with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) for all user directly contacting materials. |
| Electrical Safety and EMC | Compliant with: - IEC 60601-1 (General requirements for basic safety and essential performance) - IEC 60601-1-2 (Electromagnetic compatibility) - IEC 60601-1-11 (Home Healthcare Environment) - IEC 60601-2-83 (Particular requirements for home light therapy equipment) |
| Eye Safety | Compliant with IEC 62471 (Photobiological safety of lamps and lamp systems). |
| Software Verification and Validation (if applicable) | Consistent with moderate level of concern. System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Usability | Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
| Functional Equivalence (e.g., energy density, wavelength) | Energy density: 2.45-5 J/cm² (Similar to predicate max 5 J/cm² and within reference 3-6 J/cm²). Wavelength range: 475-1200nm (Same as predicate 475nm-1200nm, similar to reference 510-1100nm). Pulse duration: 7-10ms (Similar to predicate 11-12ms and within reference 2-10ms). Other components/features: Similar source energy, power supply, product compositions, structure design, pulsing control, delivery device, number of output channels, skin proximity sensor, software/firmware/microprocessor control. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document implicitly refers to "testing" as a general practice for device compliance rather than a specific test set of patient data.
- Biocompatibility: Tests performed on materials.
- Electrical Safety, EMC, Eye Safety: Tests performed on the device itself.
- Software V&V: Validation of the software system.
- Usability: Evaluation of human interaction with the device.
There is no mention of a traditional "test set" of patient data for efficacy evaluation, nor details about its size, provenance (country), or whether it was retrospective or prospective. This type of detail is typically not required for an IPL device's 510(k) unless specific clinical efficacy claims beyond substantial equivalence without a predicate are being made or significant clinical differences from the predicate exist. The efficacy claims are tied to the predicate and the "Indications for Use" which defines permanent hair reduction based on measurements at 6, 9, and 12 months after treatment. However, no data from such an outcomes study is presented in this summary to support this specific device's efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is not an AI/algorithm device requiring interpretation or ground truth establishment based on expert consensus for performance evaluation, there is no mention of experts or their qualifications for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of expert adjudication for this device type.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance aspects:
- Biocompatibility: Ground truth is established by the results of standardized biological tests (cytotoxicity, irritation, skin sensitization) against ISO 10993 criteria.
- Electrical Safety, EMC, Eye Safety: Ground truth is established by meeting the requirements of the referenced IEC standards.
- Software V&V: Ground truth is against the defined software requirements and risk mitigation strategies.
- Usability: Ground truth is derived from adherence to human factors and usability engineering principles and guidance.
For the Indications for Use regarding "permanent reduction in hair regrowth," the ground truth would typically come from outcomes data (measurements of hair regrowth at specific time points after treatment). However, the 510(k) summary provided does not include such outcomes data for the subject device, instead relying on substantial equivalence to the predicate device which presumably did provide such data.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm device that requires a training set.
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October 11, 2022
Hunan Guangye Biotechnology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K222432
Trade/Device Name: IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 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: ONF Dated: August 12, 2022 Received: August 12, 2022
Dear Tracy Che:
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); 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 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.
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) K222432
Device Name IPL Hair Removal Device Model(s): KCA423, KCA437, KCA439
Indications for Use (Describe)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K222432
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Hunan Guangye Biotechnology Co., Ltd. Room A701, Jinhong Park Incubation Building, No.229, Tongzipo West Road, High-tech Development Zone, Changsha, Hunan, China Post code: 410006 Tel.: +86-0755-89373426
Eileen Li Deputy general manager Tel.: +86-0755-89373426 Email: 412904775@qq.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): KCA423, KCA437, KCA439 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
Primary predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Medical Device Branch ofZhangzhou EasepalIndustrial Co., Ltd. | IPL Salon Hair ReductionSystem, Model: F60001 | K181568 | September 11, 2018 |
Reference devices:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Cyden Limited. | iPulse SmoothSkin GoldHair Removal System | K160968 | April 14, 2016 |
IV. Device Description
IPL Hair Removal Device (Model: KCA423, KCA437, KCA439), is an over-the-counter, homeuse and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works
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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. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only user with suitable skin tone can use this device.
IPL Hair Removal Device, model: KCA423, KCA437, KCA439 have the same indication for use, performance, structure design and operation, the only differences are appearance, capacitor and whether it's equipped with skin tone sensor (KCA437 and KCA439 have skin tone sensor while KCA423 does not).
V. Indications for Use
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.
VI. Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL HairRemoval DeviceKCA423 | ABS | Surface-contacting device: Intact skin | Less than 24 hours |
| IPL HairRemoval DeviceKCA437 andKCA439 | ABS, PC | Surface-contacting device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".
VII. Technological characteristics and substantial equivalence:
| Item | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) Number | K222432 | K181568 | K160968 | / |
| Trade name | IPL Hair RemovalDevice (KCA423,KCA437, KCA439) | IPL Salon HairReduction System,Model: F60001 | iPulse SmoothSkinGold Hair RemovalSystem | / |
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| Manufacturer | Hunan GuangyeBiotechnology Co.,Ltd. | Medical DeviceBranch of ZhangzhouEasepal Industrial Co.,Ltd. | Cyden Limited. | / |
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Deviceclassification | Class II | Class II | Class II | Same |
| Indication foruse/ Intendeduse | IPL Hair RemovalDevice is indicated forthe removal ofunwanted hair. Thedevice is alsoindicated for thepermanent reductionin hair regrowth,defined as the long-term, stable reductionin the number of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime. | The IPL Salon HairReduction System(Model: F60001) is anover the Counterdevice intended forthe removal ofunwanted body and/orfacial hair in adults. Itis also intended forPermanent reductionin unwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in thenumber of hairs re-growing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen. | The iPulseSmoothSkin GoldHair RemovalSystem is indicatedfor the removal ofunwanted hair. TheiPulse SmoothskinGold is alsoindicated for thepermanentreduction in hairregrowth, definedas the long-term,stable reduction inthe number of hairsregrowing whenmeasured at 6, 9and 12 months afterthe completion of atreatment regime. | Same,onlywordingdifference |
| Prescription orOTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick SkinTypes I-V | Unknown | Unknown | DifferentNote 1 |
| Treatment area | Large areas (e.g.arms, legs,underarms) and smallareas (e.g. facial hairbelow the chin line) | The device isdesigned for use onthe legs, underarms,bikini line, chest,stomach, back, arms | Unknown | Similar |
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| and on the face belowthe cheekbones. | ||||
| Device design | ||||
| Source energy | Supplied by externaladapter | Supplied by externaladapter | ExternalPowersupply | Same |
| Power supply | 100-240V~, 50/60Hz | 100-240 V AC; 50/60Hz | 110V or 230V,50/60Hz | Same |
| Productcompositions | The device mainlyincludes main unit andadapter. | Device includes atreatment windowhead, a facial adaptorand battery charger/AC cord. | The device mainlyinclude handsetand external powersupply. | Similar |
| Structuredesign | Handheld | Handheld | Handheld | Same |
| Dimension | KCA423:164.8276.440mmKCA437:16276.743.2mmKCA439:162.277.942.4mm | 143 x69.5 x 43mm(HWD) | Unknown | DifferentNote 2 |
| Weight | KCA423: 223gKCA437: 255gKCA439: 235g | 650g | Unknown | DifferentNote 2 |
| Sterilization | Not required | Not required | Not required | Same |
| Output specification | ||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | IntensePulsedLight | Same |
| Energymedium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | XenonArcFlashlamp | Same |
| Wavelengthrange | 475-1200mm | 475nm〜1200nm | 510-1100nm | Same |
| Energy density | 2.45-5J/cm² | Max 5J/cm² | 3-6J/cm² | SimilarNote 3 |
| Spot size | 3cm² | 1.72 cm² or 3.02 cm² | 3cm² (3cm by 1cm) | Same |
| Pulse duration | 7〜10ms | 11-12ms | 2ms to 10ms | SimilarNote 3 |
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Deliverydevice | Direct illumination totissue | Direct illumination totissue | Direct illumination totissue | Same |
| Number ofoutput channels | One channel | One channel | One channel | Same |
| Outputintensity level | 7 Levels | 5 levels | Unknown | DifferentNote 4 |
| Skin proximitysensor | Sensor fixed in deviceand can be moved totreatment part | Sensor fixed in deviceand can be moved totreatment part | Sensor fixed indevice and can bemoved totreatment part | Same |
| Skin tonesensor | Yes | No | Yes | Same |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Same |
| Additional features | ||||
| Skin-contactingcomponents | Enclosure and SkinContact Surface | IPL Lamp outputwindow | Enclosure andlamp window | Similar |
| Materials ofskin-contactingcomponents | KCA423: ABSKCA437 andKCA439: ABS, PC | ABS | Unknown | DifferentNote 5 |
| Biocompatibility | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements. | All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements. | Same |
| Electricalsafety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC60601-2-57 | IEC 60601-1IEC 60601-1-2IEC 60601-2-57 | Similar |
| Eye safety | IEC 62471 | Unknown | IEC 62471 | Same |
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Note 1:
Though the applicable skin tone type of the predicate device is unknown, the commonly recognized applicable skin tone types for IPL hair removal device is mostly Fitzpatrick skin types I-IV or I-V. The applicable skin tone types of the subject device is Fitzpatrick skin types I-V and usability evaluation has been conducted to verify these skin types can use the device safely and effectively, so this difference and will not raise any safety/ effectiveness problems.
Note 2:
Though the dimension and weight are different from the predicate device, this difference is insignificant and do not raise any safety/ effectiveness problems.
Note 3:
Though the energy density and pulse duration of subject device is a little different from the predicate device, they are both basically within the range of the reference device, and they all comply with IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.
Note 4:
Though the number of energy level is different from the predicate device, this difference is insignificant and do not raise any safety/ effectiveness problems since the the range of the energy density is similar to the predicate device and within the range of the reference device.
Note 5:
Though the contacting materials are not entirely same with the predicate device, both products have been tested against ISO 10993 standards and passed the tests, so this difference will not raise any safety or effectiveness issue.
Performance Data VIII.
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 IPL Hair Removal 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, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed and passed, including:
-
ISO 10993-5: 2009, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10: 2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
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Electrical safety and EMC testing were performed and passed, as per the following standards:
-
IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1-11 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.
5) Usability
The product usability has been evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016".
IX. Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference 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.