(60 days)
No
The summary does not mention AI or ML, and the device description focuses on basic sensor technology and light emission.
No.
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic or aesthetic purposes, not for treating a disease or medical condition.
No
Explanation: The device is an IPL hair removal system, indicated for the removal and permanent reduction of unwanted hair. Its function is therapeutic/cosmetic, not diagnostic. While it has a skin tone sensor, this is for safety and proper operation (to determine if the user's skin tone is suitable for treatment), not for diagnosing a medical condition.
No
The device description clearly states it is a hardware device that uses Intense Pulsed Light (IPL) and includes physical components like an external power adapter, finger switch, flash window, skin proximity sensor, and skin tone sensor. While it mentions software verification and validation, this is in the context of controlling the hardware, not as a standalone software 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 (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- This Device's Function: The IPL Hair Removal Device works by applying light energy directly to the skin to target hair follicles. It does not involve collecting or analyzing any biological specimens from the user. Its purpose is a physical treatment for hair reduction, not a diagnostic test.
The information provided clearly describes a device used for a cosmetic/therapeutic purpose (hair removal) and not for diagnosing any medical condition based on in vitro testing.
N/A
Intended Use / 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.
Product codes
ONF, OHT
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Removal of unwanted hair from large areas (e.g. arms, legs, underarms) and small areas (e.g. facial hair below the chin line).
Indicated Patient Age Range
Not Found (indicated for adults)
Intended User / Care Setting
Over-The-Counter Use / Homeuse, single-person-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 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
- Electrical Safety and EMC: 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
- Eye Safety: IEC 62471 Photobiological safety of lamps and lamp systems
- 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.
- 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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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 of | |||
| Zhangzhou Easepal | |||
| Industrial Co., Ltd. | IPL Salon Hair Reduction | ||
| System, Model: F60001 | K181568 | September 11, 2018 |
Reference devices:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Cyden Limited. | iPulse SmoothSkin Gold | ||
| Hair 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
4
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 Hair | |||
| Removal Device | |||
| KCA423 | ABS | Surface-contacting device: Intact skin | Less than 24 hours |
| IPL Hair | |||
| Removal Device | |||
| KCA437 and | |||
| KCA439 | 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 Removal | |||
| Device (KCA423, | ||||
| KCA437, KCA439) | IPL Salon Hair | |||
| Reduction System, | ||||
| Model: F60001 | iPulse SmoothSkin | |||
| Gold Hair Removal | ||||
| System | / | |||
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| Manufacturer | Hunan Guangye | |||
| Biotechnology Co., | ||||
| Ltd. | Medical Device | |||
| Branch of Zhangzhou | ||||
| Easepal Industrial Co., | ||||
| Ltd. | Cyden Limited. | / | ||
| Regulation | ||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Device | ||||
| classification | Class II | Class II | Class II | Same |
| Indication for | ||||
| use/ Intended | ||||
| 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. | The IPL Salon Hair | |||
| Reduction System | ||||
| (Model: F60001) is an | ||||
| over the Counter | ||||
| device intended for | ||||
| the removal of | ||||
| unwanted body and/or | ||||
| facial hair in adults. It | ||||
| is also intended for | ||||
| Permanent reduction | ||||
| in unwanted hair. | ||||
| Permanent hair | ||||
| reduction is defined as | ||||
| the long-term stable | ||||
| reduction in the | ||||
| number of hairs re- | ||||
| growing when | ||||
| measured at 6. 9. and | ||||
| 12 months after the | ||||
| completion of a | ||||
| treatment regimen. | The iPulse | |||
| SmoothSkin Gold | ||||
| Hair Removal | ||||
| System is indicated | ||||
| for the removal of | ||||
| unwanted hair. The | ||||
| iPulse Smoothskin | ||||
| Gold 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. | Same, | |||
| only | ||||
| wording | ||||
| difference | ||||
| Prescription or | ||||
| OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin | |||
| Types I-V | Unknown | Unknown | Different | |
| Note 1 | ||||
| Treatment area | Large areas (e.g. | |||
| arms, legs, | ||||
| underarms) and small | ||||
| areas (e.g. facial hair | ||||
| below the chin line) | The device is | |||
| designed for use on | ||||
| the legs, underarms, | ||||
| bikini line, chest, | ||||
| stomach, back, arms | Unknown | Similar | ||
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| and on the face below | ||||
| the cheekbones. | ||||
| Device design | ||||
| Source energy | Supplied by external | |||
| adapter | Supplied by external | |||
| adapter | External | |||
| Power | ||||
| supply | Same | |||
| Power supply | 100-240V~, 50/60Hz | 100-240 V AC; 50/60 | ||
| Hz | 110V or 230V, | |||
| 50/60Hz | Same | |||
| Product | ||||
| compositions | The device mainly | |||
| includes main unit and | ||||
| adapter. | Device includes a | |||
| treatment window | ||||
| head, a facial adaptor | ||||
| and battery charger/ | ||||
| AC cord. | The device mainly | |||
| include handset | ||||
| and external power | ||||
| supply. | Similar | |||
| Structure | ||||
| design | Handheld | Handheld | Handheld | Same |
| Dimension | KCA423: | |||
| 164.8276.440mm | ||||
| KCA437: | ||||
| 16276.743.2mm | ||||
| KCA439: | ||||
| 162.277.942.4mm | 143 x69.5 x 43mm | |||
| (HWD) | Unknown | Different | ||
| Note 2 | ||||
| Weight | KCA423: 223g | |||
| KCA437: 255g | ||||
| KCA439: 235g | 650g | Unknown | Different | |
| Note 2 | ||||
| Sterilization | Not required | Not required | Not required | Same |
| Output specification | ||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense | |
| Pulsed | ||||
| Light | Same | |||
| Energy | ||||
| medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon | |
| Arc | ||||
| Flashlamp | Same | |||
| Wavelength | ||||
| range | 475-1200mm | 475nm〜1200nm | 510-1100nm | Same |
| Energy density | 2.45-5J/cm² | Max 5J/cm² | 3-6J/cm² | Similar |
| Note 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 | Similar |
| Note 3 | ||||
| Item | Subject Device | Predicate Device | Reference Device | Remark |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Delivery | ||||
| device | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Same | |||
| Number of | ||||
| output channels | One channel | One channel | One channel | Same |
| Output | ||||
| intensity level | 7 Levels | 5 levels | Unknown | Different |
| Note 4 | ||||
| Skin proximity | ||||
| sensor | Sensor fixed in device | |||
| and can be moved to | ||||
| treatment part | Sensor fixed in device | |||
| and can be moved to | ||||
| treatment part | Sensor fixed in | |||
| device and can be | ||||
| moved to | ||||
| treatment part | Same | |||
| Skin tone | ||||
| sensor | Yes | No | Yes | Same |
| Software/ | ||||
| Firmware/ | ||||
| Microprocessor | ||||
| Control? | Yes | Yes | Yes | Same |
| Additional features | ||||
| Skin- | ||||
| contacting | ||||
| components | Enclosure and Skin | |||
| Contact Surface | IPL Lamp output | |||
| window | Enclosure and | |||
| lamp window | Similar | |||
| Materials of | ||||
| skin-contacting | ||||
| components | KCA423: ABS | |||
| KCA437 and | ||||
| KCA439: ABS, PC | ABS | Unknown | Different | |
| Note 5 | ||||
| Biocompatibility | All user directly | |||
| contacting materials | ||||
| are compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | All user directly | |||
| contacting materials | ||||
| are compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | All user directly | |||
| contacting | ||||
| materials are | ||||
| compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | Same | |||
| Electrical | ||||
| safety | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-57 | Similar | |||
| Eye safety | IEC 62471 | Unknown | IEC 62471 | Same |
5
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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
9
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.