(83 days)
No
The summary does not mention AI or ML, and the device description focuses on basic sensor and light emission technology.
No.
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic purposes rather than for treating a disease or condition.
No
The device is an IPL hair removal device intended for the removal and permanent reduction of unwanted hair, not for diagnosing any 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, treatment window, skin sensor, and cooling function. While it mentions software verification and validation, this is for the control and operation of the hardware, not a standalone software medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth. This is a physical treatment applied to the body, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a device that emits light to affect hair follicles. It does not describe any components or processes related to analyzing biological samples.
- Lack of Diagnostic Function: The device's function is to treat, not to diagnose a condition or provide information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This IPL hair removal device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Hair Removal Device (Model: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal 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 treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
large areas (e.g. arms, legs, chest) and small areas (e.g. lip)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use; home-use and personal device
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 to, and passed, including:
- ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- ANSI AAMI ES60601-1 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 disturbances -Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems
-
Software Verification and Validation: 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 the following standard and FDA guidance
- IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Summary: Based on the above performance as documented in this application, IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the date April 10, 2023. The date is written in a simple, clear font. The text is centered and takes up a small portion of the image.
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
Shenzhen Ulike Smart Electronics Co., Ltd % 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: K230122
Trade/Device Name: IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG 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 15, 2023 Received: January 17, 2023
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 (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.
1
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 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.
Colin K. Chen -S
for
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
2
Indications for Use
510(k) Number (if known) K230122
Device Name IPL Hair Removal Device Model(s): UI04 SD, UI04 DG
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)
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Shenzhen Ulike Smart Electronics Co.,Ltd.
No.8, Keyuan Road, Yuehai Sub-district, Nanshan District, Shenzhen, Guangdong, China Post code: 518000 Tel.: +86 18600825411
Shane Xie Registration Director Tel: +86 18600825411 Email: Shane@ulikebeauty.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): UI04 SD, UI04 DG 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 |
|---|---|---|---|
| CyDen Limited. | iPulse SmoothSkin Gold | ||
| Hair Removal System | K160968 | Apr.14, 2016 |
Predicate device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shen Zhen CosBeauty Co., Ltd | IPL Hair Removal Device | ||
| Joy Version, CB-027 | K173813 | Sept. 07, 2018 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Dongguan Define Beauty | |||
| Electronic Technology Co. | |||
| Ltd | IPL HAIR REMOVAL SG- | ||
| 8025 | K212318 | Jan.14, 2022 |
4
IV. Device Description
IPL Hair Removal Device (Model: UI04 SD, UI04 DG), is an over-the-counter, home-use and personal 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 treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin 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. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
IPL Hair Removal Device, model: UI04 SD, UI04 DG have the same indication for use, performance, structure design and operation, the only deference is their enclosure color (UI04 SD is Star White and UI04 DG is Dark Green).
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 (Enclosure | |||
| and treatment | |||
| window) | ABS, PC, | ||
| Crystal application | 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 "Biocompatibility Discussion".
VII.Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device and reference devices. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices and reference device.
IPL Hair Removal Device is compared with the following Predicate Devices and Reference Device in terms of intended use, design, specifications and performance:
5
| Comparison
| Elements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark | |
|---|---|---|---|---|---|---|
| 510(k) | ||||||
| Number | Pending | K160968 | K173813 | K212318 | / | |
| Trade name | IPL Hair Removal | |||||
| Device | iPulse SmoothSkin | |||||
| Gold Hair Removal | ||||||
| System | IPL Hair Removal | |||||
| Device Joy Version, CB- | ||||||
| 027 | IPL HAIR | |||||
| REMOVAL SG- | ||||||
| 8025 | / | |||||
| Manufacturer | Shenzhen Ulike | |||||
| Smart Electronics | ||||||
| Co.,Ltd. | Cyden Limited. | Shen Zhen CosBeauty | ||||
| Co., Ltd | Dongguan Define | |||||
| Beauty Electronic | ||||||
| Technology Co. | ||||||
| Ltd | / | |||||
| Regulation | ||||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| Product code | OHT | OHT, GEX | OHT | OHT | Same | |
| Device | ||||||
| classification | Class II | 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 | |||||
| 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. | The IPL Hair Removal | |||||
| Device Joy Version 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 | ||||||
| device is used for adults | ||||||
| with Fitzpatrick skin | ||||||
| types I - IV. | The IPL Hair | |||||
| Removal (Model: | ||||||
| SG-8025) 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. | Same, | |||||
| only wording | ||||||
| difference | ||||||
| Prescription | ||||||
| or OTC | OTC | OTC | OTC | OTC | Same | |
| Applicable | Fitzpatrick | |||||
| Skin | Unknown | Fitzpatrick skin types I - | Unknown | Different | ||
| Comparison | ||||||
| Elements | Subject Device | Primary Device | Predicate Device | Reference Device | Remark | |
| skin | Types I-V | IV | ||||
| Treatment | ||||||
| area | large areas (e.g. arms, | |||||
| legs, chest) and small | ||||||
| areas (e.g. lip) | Unknown | Large areas (legs, arms, | ||||
| back and abdomen), face | ||||||
| (upper lip, chin and | ||||||
| sideburns) | Body and face | Similar | ||||
| Device design | ||||||
| Source | ||||||
| energy | Supplied by external | |||||
| adapter | External Power | |||||
| supply | Supplied by external | |||||
| adapter | Supplied by | |||||
| external adapter | Same | |||||
| Power supply | 100~240V, 50/60Hz | 110V or 230V, | ||||
| 50/60Hz | 100-240 VAC, 50/60Hz | Unknown | Same | |||
| Dimension | 60mm x | |||||
| 38mm x | ||||||
| 170mm | Unknown | 12678200mm | 2057656mm | |||
| (HWD) | Different | |||||
| Sterilization | Not required | Not required | Not required | Not required | Same | |
| Output specification | ||||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed | ||
| Light | Same | |||||
| Energy | ||||||
| medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon lamp | Same | |
| Wavelength | ||||||
| range | 560-1200nm | 510-1100nm | 510-1200nm | 530nm | Similar | |
| Energy | ||||||
| density | 2.4-7.2J/cm2 | 3-6J/cm2 | 1.8~5.1J/cm2 | 2.5J/cm2 Max | Similar | |
| Output | ||||||
| energy | 9.9~19.8J | 9~18J | Body | |||
| lamp | ||||||
| cartridge | 11.77~22.21J | |||||
| 510-1200nm | Level 1: 7.5J | |||||
| Level 2: 8.5J | ||||||
| Level 3: 9.5J | ||||||
| Level 4: 11J | ||||||
| Level 5: 12J | Similar | |||||
| Facial | ||||||
| lamp | ||||||
| cartridge | 3.65~7.04J | |||||
| 512-1197nm | ||||||
| Bikini | ||||||
| lamp | ||||||
| cartridge | 3.84~7.22J | |||||
| 511-1200nm | ||||||
| Spot size | 3.3cm2 | 3cm2 (3cm by 1cm) | Body: 4.2cm2 | |||
| Bikini and face: 2.0cm2 | 3.0cm2 | Similar | ||||
| Pulse | ||||||
| duration | 1.15-6.2ms | 2ms to 10ms | 9.2~11.2ms | 1ms | Different | |
| Pulsing | ||||||
| control | Finger switch | Finger switch | Finger switch | Finger switch | Same | |
| Delivery | ||||||
| device | Direct illumination to | |||||
| tissue | Direct illumination to | |||||
| tissue | Direct illumination to | |||||
| tissue | Direct illumination | |||||
| to tissue | Same | |||||
| Output | ||||||
| intensity level | 5 | Unknown | 5 | 5 | Same | |
| Comparison | ||||||
| Elements | Subject Device | Primary | ||||
| Predicate | ||||||
| Device | Predicate Device | Reference Device | Remark | |||
| Software/ | ||||||
| Firmware/ | ||||||
| Microprocess | ||||||
| or Control? | Yes | Yes | Yes | Yes | Same | |
| Additional features | ||||||
| Electrical | ||||||
| safety | ANSI | |||||
| ES60601-1 | ||||||
| IEC 60601-1-2 | ||||||
| IEC 60601-1-11 | ||||||
| IEC 60601-2-57 | ||||||
| IEC 60601-2-83 | AAMI | |||||
| IEC 60601-1 | ||||||
| IEC 60601-1-2 | ||||||
| IEC 60601-2-57 | IEC 60601-1 | |||||
| IEC 60601-1-2 | ||||||
| IEC 60601-2-57 | IEC 60601-1 | |||||
| IEC 60601-1-2 | ||||||
| IEC 60601-1-11 | ||||||
| IEC 60601-2-57 | Similar | |||||
| Eye safety | IEC 62471 | IEC 62471 | Unknown | IEC 62471 | Same | |
| Biocompatibi | ||||||
| lity | ISO 10993-5 | |||||
| ISO 10993-10 | ISO 10993-5 | |||||
| ISO 10993-10 | ISO 10993-5 | |||||
| ISO 10993-10 | ISO 10993-5 | |||||
| ISO 10993-10 | Same |
6
7
Shenzhen Ulike Smart Electronics Co.,Ltd. 510(k)s -Section 8. 510(k) Summary
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 to, and passed, including:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
ANSI AAMI ES60601-1 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 disturbances -Requirements and tests
8
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
-
IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
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 the following standard and FDA guidance
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Summary
Based on the above performance as documented in this application, IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.
IX. Conclusions
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 devices.