(82 days)
No
The summary describes a standard IPL device with basic safety features like a skin sensor and cooling function. There is no mention of AI, ML, or any advanced processing that would suggest such technology is incorporated. The performance studies listed are standard for this type of device and do not indicate AI/ML evaluation.
No.
The device is used for cosmetic hair removal and reduction, which is not considered a therapeutic medical treatment.
No
The device is an IPL hair removal device for reducing unwanted hair, not for diagnosing any medical condition or disease. Its function is cosmetic/treatment-oriented, not diagnostic.
No
The device description clearly outlines a physical device that emits Intense Pulsed Light (IPL) and includes hardware components such as a power adapter, finger switch, light exit, skin sensor, and cooling function. While software verification and validation are mentioned, the device itself is not solely software.
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 for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device uses Intense Pulsed Light applied to the skin's surface to reduce hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the removal and permanent reduction of unwanted hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The description clearly indicates it's a home-use device for a physical treatment applied externally to the body.
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
OHT
Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device 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.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm² (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line).
The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home-use device / Over-The-Counter 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 Evaluation: 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.
- Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility.
- IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance .
- IEC 60601-1-11:2015/AMD1:2020 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 60601-2-83:2019 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.
- Eye Safety: IEC 62471:2006 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 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2024
Zhuzhou Goldenhot Medical Technology Co.,Ltd. % Candice Oiu Registration Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K243085 Trade/Device Name: IPL Hair Removal Device (DE03A-W, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) 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: September 29, 2024 Received: September 30, 2024
Dear Candice Qiu:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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
2
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,
Digitally signed by YAN FU -S
YAN FU -S Date: 2024.12.21 11:45:08
-05'00'
for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243085
Device Name IPL Hair Removal Device Model(s): DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G
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."
4
510(k) Summary-K243085
"510(k) Summary" as required by 21 CFR Part 807.92. December 11, 2024
I. Submitter
Zhuzhou Goldenhot Medical Technology Co.,Ltd. Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District, Zhuzhou City, Hunan Province, China Liu Xianwu Deputy Manager Tel: +86 13808497058 Email: 2569981973@qq.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G. 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 and Reference Device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen IONKA Medical | |||
| Technology Co., Ltd. | Hand-held IPL device (IPL | ||
| Home Use Hair Removal | |||
| Device), | |||
| (Model: FZ-608, FZ-608G, | |||
| FZ-100, FZ-200) | K230739 | May 26, 2023 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Zhuzhou | |||
| Medical | |||
| Co.,Ltd. | Intense pulsed light device | ||
| (Model: DE01A-B, DE01A-G, DE01B-B, DE01B-G, | |||
| DE01C-B, DE01C-G, DE02A-B, DE02A-G, | |||
| DE02B-B, DE02B-G, DE02C-B, DE02C-G) | K231613 | July 31, 2023 |
5
IV. Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device 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.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm2 (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line).
The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
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) | ABS,PC,POM, Stainless | ||
| steel, Fiberglass | Surface-contacting | ||
| device: Intact skin | Less than 24 hours |
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. Any minor differences between the subject device and the listed predicate device and reference device do no raise any issues of safety or efficacy.
6
Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference device.
IPL Hair Removal Device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material, specifications, and performance:
| Comparison
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) Number | K243085 | K230739 | K231613 | / |
| Trade name | IPL Hair Removal | |||
| DeviceDE03A-W, | ||||
| (Model: DE03A-W, | ||||
| DE03A-P, DE03A-V, | ||||
| DE03A-G, DE03B-W, | ||||
| DE03B-P, DE03B-V, | ||||
| DE03B-G.) | Hand-held IPL device | |||
| (IPL Home Use Hair | ||||
| Removal Device), | ||||
| (Model: FZ-608FZ- | ||||
| 608G,FZ-100.FZ-200) | Intense pulsed light | |||
| device | ||||
| (Model: DE01A-B, | ||||
| DE01A-G, DE01B-B, | ||||
| DE01B-G, DE01C-B, | ||||
| DE01C-G, DE02A-B, | ||||
| DE02A-G, DE02B-B, | ||||
| DE02B-G, DE02C-B, | ||||
| DE02C-G) | ||||
| Manufacturer | Zhuzhou Goldenhot | |||
| Medical Technology | ||||
| Co.,Ltd. | Shenzhen IONKA | |||
| Medical Technology Co., | ||||
| Ltd. | Zhuzhou Goldenhot | |||
| Medical Technology | ||||
| Co.,Ltd. / | / | |||
| 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 | The 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 Home Use 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 Intense pulsed light | |||
| device is an over-the- | ||||
| counter device, intended | ||||
| for removal of unwanted | ||||
| body and/or facial hair. | Same | |||
| Prescription or OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick skin types I-V | Unknown | Fitzpatrick Skin Types I- | |
| V | Same | |||
| Comparison | ||||
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
| Power supply | 100-240V, 50/60Hz | Supplied by external adapter | 100~240V , 50/60 Hz | Same |
| Dimension | DE03A-W, | |||
| DE03A-P, | ||||
| DE03A-V, | ||||
| DE03A-G, | ||||
| DE03B-W, | ||||
| DE03B-P, | ||||
| DE03B-V, | ||||
| DE03B-G: | ||||
| 176.1(W)x60.66(H)x38.76 | ||||
| (L)mm | FZ-608, | |||
| FZ-608G: | ||||
| 9814760(mm) | ||||
| FZ-100: 1987144(mm) | ||||
| FZ-200: 2166852(mm) | DE01A-B, | |||
| DE01A-G: | ||||
| 218(W)x77(H)x97(L)mm | ||||
| DE01B-B, | ||||
| DE01B-G, | ||||
| DE01C-G: | ||||
| DE01C-B, | ||||
| 218(W)x77(H)x103(L)m | ||||
| m DE02A-B, DE02A-G: | ||||
| 178(W)x67(H)x150(L)m | ||||
| m | ||||
| DE02B-B, | ||||
| DE02B-G, | ||||
| DE02C-B, | ||||
| DE02C-G: | ||||
| 183(W)x67(H)x150(L)m | ||||
| m | Different | |||
| Sterilization | Not required | Not required | Not required | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Flashlamp | Xenon Arc Flashlamp | Xenon Flashlamp | Same |
| Wavelength range | 510-1200nm | 510nm~1200nm | 510-1200nm | Same |
| Energy density | 1.2~3.0 J/cm² | FZ-608, FZ-608G: 3.33 J/cm² | ||
| FZ-100: 5.43 J/cm2 | ||||
| FZ-200: 4.5 J/cm2 | Body mode: 1.2 ~ 4.1 | |||
| J/cm² | ||||
| Face mode : 1.2 ~ 4.1 | ||||
| J/cm² | ||||
| Bikini mode: 1.2 ~ 4.1 | ||||
| J/cm² | Similar | |||
| Output energy | 5~9J | FZ-608, FZ-608G: | ||
| Level 1: 4.16J | ||||
| Level 2: 4.36J | ||||
| Level 3: 5.1J | ||||
| Level 4: 6.1J | ||||
| Level 5: 6.96J | ||||
| Level 6: 7.96J | ||||
| Level 7: 8.63J | ||||
| Level 8: 9.13J | ||||
| Level 9: 10.0J | Body: 6.4-14.0 J | |||
| Face: 5.6-11.9 J | ||||
| Bikini line: 5.7-12.8 J | Similar | |||
| Spot size | 3.0cm² | 3.0cm² | 3.9 cm² | Similar |
| Pulse duration | 9.3 ±1.86 ms | 0.5~0.8 ms | Body mode: | |
| 7.0±2.0 ~ | ||||
| 9.0±2.0 ms | ||||
| Face mode: | ||||
| 8.0±2.0 ~ | ||||
| 10.0±2.0 ms | ||||
| Bikini mode: 9.0±2.0 ~ | ||||
| 11.0±2.0 ms | Similar | |||
| Comparison | ||||
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Output intensity | ||||
| level | 3 levels | FZ-608, FZ-608G: 9 levels | ||
| FZ-100: 9 levels | ||||
| FZ-200: 6 levels | 5 Levels | Different | ||
| Software/ | ||||
| Firmware/ | ||||
| Microprocessor | ||||
| Control? | Yes | Yes | Yes | Same |
| Electrical safety | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | ANSI AAMI ES60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | Same | |||
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | Same |
7
8
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Evaluation
-
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.
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1-2:2014+A1:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility.
-
IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance .
-
IEC 60601-1-11:2015/AMD1:2020 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.
9
-
IEC 60601-2-83:2019 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.
3) Eye Safety
-
IEC 62471:2006 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 FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016.
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 device.