(30 days)
Not Found
No
The summary describes a device using standard IPL technology with a skin sensor and cooling function. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which falls under cosmetic/aesthetic use rather than a therapeutic indication for treating a disease or disorder.
No
This device is indicated for hair removal and permanent reduction in hair regrowth, which are therapeutic or cosmetic purposes, not diagnostic. It does not identify or diagnose a disease or condition.
No
The device description clearly outlines hardware components such as a Xenon lamp, skin sensor, and cooling function, and mentions being powered by an external adapter. While software verification and validation were performed, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The core function of an IVD is to examine biological samples (like blood, urine, tissue, etc.) to provide information about a person's health or condition.
- This device uses light to interact with the body. The Ice Cooling IPL Home Use Hair Removal Device uses Intense Pulsed Light (IPL) to target hair follicles on the skin. It does not collect or analyze any biological samples.
- The intended use is hair removal. The stated purpose of the device is to reduce unwanted hair growth. This is a physical interaction with the body, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair 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
The Ice Cooling IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light technology and it has the cooling function that effectively cools the skin.
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. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process or when the user want to activated to provide users with a more comfortable experience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarm, facial hair below the chin line, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (OTC)
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)
Non-clinical tests have been conducted to verify that the Ice Cooling IPL Home Use Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device conforms to the following performance standards:
- A 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 A basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A 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
- A IEC 60601-2-57, Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- IEC 60601-2-83, Medical electrical equipment Part 2-83: Particular A requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471, Photobiological safety of lamps and lamp systems
- IEC 62366-1, Medical devices Part 1: Application of usability engineering to medical devices
The device has been tested for biocompatibility for conformance to the following performance standards:
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation
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.
K240264, K223618, K221002, K173813
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.
Not Found
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 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Shenzhen Mlay Intelligent Technology Co., Ltd. Libin Liu General Manager 302,401, Building 1, No. 2, Xiashiwei Road, Huaide Community Fuyong Street, Baoan District Shenzhen. 518000 China
Re: K241106
Trade/Device Name: Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C. T15A. T17A, T18A, T14A, T16A, T19A) 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: April 22, 2024 Received: April 22, 2024
Dear Libin Liu:
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 (the 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 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"
1
(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 OS 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.
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 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.
Yan Fu -S
Digitally signed by Yan Fu -S
Date: 2024.05.22 13:31:27
-04'00'
for
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241106
Device Name
Ice Cooling IPL Home Use Hair Removal; Device Model(s): T10B, T10C, T15A, T17A, T18A, T19A
Indications for Use (Describe)
The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small as underarm and facial hair below the chin line and large areas such as legs.
The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair 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) |
|---|
| ------------------------------------------------- |
Research Use (21 CFR 201.3 Subject to)
Non-Therapeutic Use (21 CFR 201.3 Subject to)
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary - K241106 "510(k) Summary" as required by 21 CFR Part 807.92.
1. Submitter Information
Shenzhen Mlay Intelligent Technology Co., Ltd. 302,401, Building 1, No. 2, Xiashiwei Road, Huaide Community, Fuyong Street, Baoan District, Shenzhen, Guangdong, China
Post Code: 518000
LIU LIBIN General Manager Tel.: +86 150 6071 0113 Email: amy@mlays.com
2. Device Information
| Trade name: | Ice Cooling IPL Home Use Hair Removal Device |
|---|---|
| Model(s): | T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A |
| Common Name: | Light Based Over-The-Counter Hair Removal |
| Regulation Class: | Class II |
| Product Code: | OHT |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 21CFR 878.4810 |
| Regulation Description: | Laser surgical instrument for use in general and plastic |
| surgery | |
| Submission Type: | Special 510(k) |
3. Predicate Device
Primary predicate device:
| Manufacturer | Predicate Device | 510k Number | Decision Date |
|---|---|---|---|
| Shenzhen Mlay | |||
| Intelligent | |||
| Technology Co., | |||
| Ltd | Home Use Hair Removal | ||
| Device (Model(s):T10A, | |||
| T10B, T10C, T10D, T11A, | |||
| T15A, T17A, T18A, T14A, | |||
| T16A, T19A) | K240264 | March 8, 2024 |
Predicate device:
| Manufacturer | Predicate Device | 510k Number | Decision Date |
|---|---|---|---|
| Shenzhen Ulike | |||
| Smart Electronics | |||
| Co.,Ltd | IPL Hair Removal Device | K223618 | Feb. 28, 2023 |
| Shenzhen Ulike | |||
| Smart Electronics | IPL Hair Removal Device | K221002 | June 01, 2022 |
5
| Co.,Ltd | |||
|---|---|---|---|
| Shen Zhen | |||
| CosBeauty Co., | |||
| Ltd | IPL Hair Removal Device | ||
| Joy Version | K173813 | Sept. 07, 2018 |
4. Device Description
The Ice Cooling IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light technology and it has the cooling function that effectively cools the skin.
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. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process or when the user want to activated to provide users with a more comfortable experience.
5. Indications for Use
The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
6. Comparison of Technological Characteristics With the Predicate Device
The Ice Cooling IPL Home Use Hair Removal Device has the same intended use, mode of action and operational characteristics as the models T10B, T15A, T17A, T18A, T14A, T16A, T19 in the predicate devices. The modification between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the primary predicate device and predicate device for its intended use. Therefore, the Ice Cooling IPL Home Use Hair Removal Device may be found substantially equivalent to its predicate device.
Ice Cooling IPL Home Use Hair Removal Device is compared with the primary predicate device and predicate device as belows:
6
| Comparison
| Elements | Subject Device | Primary Predicate Device K240264 | Comparison |
|---|---|---|---|
| K Number | Pending | K240264 | / |
| Trade name | Ice Cooling IPL Home Use Hair Removal | ||
| Device, Model(s): T10B, T10C, T15A, | |||
| T17A, T18A, T14A, T16A, T19A | Home use hair removal device, Model(s): | ||
| T10A, T10B, T10C, T10D, T11A, T15A, | |||
| T17A, T18A, T14A, T16A, T19A | Similar | ||
| Note¹ | |||
| Location | |||
| for | |||
| use | OTC | OTC | SE |
| Indications for | |||
| Use | The Ice Cooling IPL Home Use Hair | ||
| Removal Device is an over-the-counter | |||
| device indicated | |||
| for the removal | |||
| of | |||
| unwanted hair such as but not limited to | |||
| small areas such as underarm and facial hair | |||
| below the chin line and large areas such as | |||
| legs. | |||
| The device is also indicated for the | |||
| permanent reduction in hair regrowth, | |||
| defined as the long term, stable reduction in | |||
| the amount of hair regrowing when | |||
| measured at 6, 9 and 12 months after the | |||
| completion of a treatment regime. | The Home use hair removal device is an | ||
| over-the-counter device intended for | |||
| removal of unwanted hair such as but not | |||
| limited to small areas such as underarm and | |||
| facial hair below the chin line and large | |||
| areas such as legs, in patients with | |||
| Fitzpatrick Skin Phototypes I-V. | Similar | ||
| Note2 | |||
| Ice cooling | |||
| function | Model(s): T10B, T10C, T15A, T17A, | ||
| T18A, T14A, T16A, T19A have cooling | |||
| function | (1)Model(s): T10A, T10D, T11A | ||
| do not | |||
| have cooling function. | |||
| (2)Model(s): T10B, T10C, T15A, T17A, | |||
| T18A, T14A, T16A, T19A have cooling | |||
| function | SE | ||
| Note3 | |||
| Cooling | |||
| panel's | |||
| material | T10B, T10C: artificial sapphire | ||
| T15A, T17A, T18A, T14A, T16A, T19A: | |||
| 5052 aluminum alloy | T10A,T10D,T 11A: have not cooling | ||
| function | |||
| T10B, T10C: artificial sapphire | |||
| T15A, T17A, T18A, T14A, T16A, T19A: | |||
| 5052 aluminum alloy | |||
| Energy | |||
| medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE |
| Light Source | Intense Pulsed Light | Intense Pulsed Light | SE |
| Pulsing | |||
| control | Finger switch | Finger switch | SE |
| Delivery | |||
| device | Direct illumination tissue | Direct illumination tissue | SE |
| Energy density | T10B, T10C, T15A, T17A, T18A: $1.37 ~ 4.11J/cm²$ | ||
| T14A,T16A,T19A: $1.84~ 5.23J/cm²$ | T10A, T10B, T10C, T10D, T11A, T15A, | ||
| T17A, T18A: $1.37~4.11J/cm²$ | |||
| T14A,T16A,T19A: $1.84~ 5.23J/cm²$ | SE | ||
| Comparison | |||
| Elements | Subject Device | Primary Predicate Device K240264 | Comparison |
| K Number | Pending | K240264 | / |
| Treatment | |||
| energy level | (1)Model(s)T17A,T18A:have 3 levels; | ||
| Level 1 to Level 3 | |||
| (2)Model(s)T10B, T10C, T15A, T14A, | |||
| T16A, T19A: have 5 levels; Level 1 to | |||
| Level 5 | (1)Model(s)T11A,T17A,T18A:have 3 | ||
| levels; Level 1 to Level 3 | |||
| (2)Model(s)T10A, T10B, T10C, T10D, | |||
| T15A, T14A, T16A, T19A: have 5 levels; | |||
| Level 1 to Level 5 | SE | ||
| Note3 | |||
| Spot size | T10B,T10C,T15A,T17A,T18A: 3.5cm² | ||
| T14A,T16A,T19A: 3.9cm² | T10A, T10B, T10C, T10D, T11A, T15A, | ||
| T17A, T18A: 3.5cm² | |||
| T14A,T16A,T19A: 3.9cm² | SE | ||
| Pulse duration | T10B, T10C,T15A, T17A, T18A: | ||
| 4.0~8.0ms | |||
| T14A,T16A,T19A: 0.5~2.5ms | T10A, T10B, T10C, T10D, T11A, T15A, | ||
| T17A, T18A: 4.0~8.0ms | |||
| T14A,T16A,T19A: 0.5~2.5ms | SE | ||
| Pulse interval | T10B, T10C: 0.5~2.8s | ||
| T15A, T17A, T18A: 0.7~2.5s | |||
| T14A,T16A,T19A: 0.5~1.5s | T10A, T10B, T10C, T10D: 0.5~2.8s | ||
| T11A: 1.0~2.5s | |||
| T15A, T17A, T18A: 0.7~2.5s | |||
| T14A,T16A,T19A: 0.5~1.5s | SE | ||
| Treatment | |||
| window to be | |||
| designed as | |||
| removable or | |||
| non-removable | (1)Model(s) T10B, T10C,T15A, T17A, | ||
| T18A:non-removable | |||
| (2)Model(s)T14A,T16A,T19A:removable | (1)Model(s)T10A, T10B, T10C, T10D, | ||
| T11A,T15A,T17A,T18A:non-removable | |||
| (2)Model(s)T14A,T16A,T19A:removable | SE | ||
| Note3 | |||
| Design | |||
| Software | |||
| Features | |||
| Materials | |||
| Energy source | |||
| Principle of | |||
| operation | The models applied for this time are exactly the same as these models T10B, T10C, T15A, | ||
| T17A, T18A, T14A, T16A, T19A in K240264. | SE |
7
8
| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| K Number | Pending | K223618 | K221002 | K173813 | / |
| Trade name | Ice Cooling IPL Home Use Hair | ||||
| Removal Device, Model(s): | |||||
| T10B, T10C, T15A, T17A, | |||||
| T18A, T14A, T16A, T19A | IPL Hair Removal | ||||
| Device | IPL Hair Removal | ||||
| Device (UI04A, UI04B, | |||||
| UI04C) | IPL Hair Removal | ||||
| Device Joy Version, CB- 027 | Similar | ||||
| Note1 | |||||
| Location for use | OTC | OTC | OTC | OTC | SE |
| Indications for Use | The Ice Cooling IPL Home Use | ||||
| Hair Removal Device is an | |||||
| over-the-counter device | |||||
| indicated for the removal of | |||||
| unwanted hair such as but not | |||||
| limited to small areas such as | |||||
| underarm and facial hair below | |||||
| the chin line and large areas | |||||
| such as legs. | |||||
| The device is also indicated for | |||||
| the permanent reduction in hair | |||||
| regrowth, defined as the long | |||||
| term, stable reduction in the | |||||
| amount of hair regrowing when | |||||
| measured at 6, 9 and 12 months | 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 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 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. | Similar | ||||
| Note2 | |||||
| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
| K Number | Pending | ||||
| after the completion of a | |||||
| treatment regime. | K223618 | K221002 | K173813 | / | |
| Applicable skin | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types I-V | Fitzpatrick Skin Types | ||
| I-V | Fitzpatrick skin types I - IV | Similar | |||
| Treatment area | Large areas(e.g. legs) and small | ||||
| areas(e.g.underarm, facial hair | |||||
| below the chin line) | Large areas (e.g. arms, legs, | ||||
| chest) and small areas (e.g. | |||||
| lip) | Large areas (e.g.arms, | ||||
| legs, chest) and small | |||||
| areas (e.g. fingers, lip) | Large areas (legs, arms, back | ||||
| and abdomen), face | |||||
| (upper lip, chin and | |||||
| sideburns) | Similar | ||||
| Output specification | |||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | SE |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE |
| Wavelength range | 510~1200nm | 560~1200nm | 550~1200nm | 510~1200nm | Similar |
| Note4 | |||||
| Energy density | T10B, T10C, T15A, T17A, | ||||
| T18A: 1.37~4.11J/cm² | |||||
| T14A,T16A, T19A: 1.84 ~ | |||||
| 5.23J/cm² | 3~6J/cm² | 3.03~5.3J/cm² | 1.8~5.1J/cm² | Similar | |
| Note5 | |||||
| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
| K Number | Pending | K223618 | K221002 | K173813 | / |
| Output energy | T10B, T10C, T15A, 17A,T18A: | ||||
| 6~12J | |||||
| T14A, T16A, T19A: 9~ 17J | 9.9~19.8J | 10.0~17.5J | Body | ||
| lamp | |||||
| cartridge | |||||
| 11.77~22.21J | |||||
| 510~1200nm | Similar | ||||
| Note5 | |||||
| Facial | |||||
| lamp | |||||
| cartridge | |||||
| 3.65~7.04J | |||||
| 512~1197nm | |||||
| Bikini | |||||
| lamp | |||||
| cartridge | |||||
| 3.84~7.22J | |||||
| 511~1200nm | |||||
| Spot size | T10B, T10C, T15A, 17A,T18A: | ||||
| 3.5cm² | |||||
| T14A, T16A, T19A: 3.9cm² | 3.3cm² | 3.3cm² | Body: 4.2cm² | ||
| Bikini and face: 2.0cm² | Similar | ||||
| Note6 | |||||
| Pulse duration | T10B, T10C, T15A, 17A,T18A: | ||||
| 4.0~8.0ms | |||||
| T14A, T16A, T19A: 0.5~2.5ms | 1~7ms | 7~10ms | 9.2~11.2ms | Similar | |
| Note7 | |||||
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | SE |
| Delivery device | Direct illumination tissue | Direct illumination tissue | Direct illumination tissue | Direct illumination tissue | SE |
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| K Number | Pending | K223618 | K221002 | K173813 | / |
| Output intensity level | T17A,T18A: 3 levels | ||||
| T10B, T10C, T15A, T14A, | |||||
| T16A, T19A: 5 levels | 3 levels | 5 levels | 5 levels | Similar | |
| Software/ Firmware/ | |||||
| Microprocess or Control | Yes | Yes | Yes | Yes | SE |
| Additional features | |||||
| Electrical safety | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-6 | |||||
| IEC 60601-1-11 | |||||
| IEC 60601-2-57 | |||||
| IEC 60601-2-83 | ANSI AAMI ES60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| IEC 60601-2-57 | |||||
| IEC 60601-2-83 | IEC 60601-1-2 | ||||
| IEC 60601-1-11 | |||||
| ANSI AAMI | |||||
| ES60601-1 | |||||
| IEC 60601-2-57 | |||||
| IEC 60601-2-83 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-57 | Similar |
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| Comparison Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate Device 3 | Comparison |
|---|---|---|---|---|---|
| K Number | Pending | K223618 | K221002 | K173813 | / |
| Eye safety | IEC62471 | IEC 62471 | IEC 62471 | IEC 62471 | SE |
| Biocompatibility | ISO 10993-5 | ||||
| ISO 10993-10 | |||||
| ISO 10993-12 | ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-5 | ||||
| ISO 10993-10 | Similar |
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Notel: These model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A all provide hair reduction using Intense Pulsed Light technology and it has the cooling function that effectively cools the skin, so the device name changes from " Home use hair removal device" to "Ice Cooling IPL Home Use Hair Removal Device". The user can get the information about the function of the device by the device name, which is convenient for the user to self-select for the device.
Note2:The Indications for Use descriptions of the subject device and the predicate device are essentially the same, except that the wording is different. 1) The user manual and the outer packaging label specify the hair colors that the device can be used to treat, so the words "in patients with Fitzpatrick Skin Phototypes I-V" have been deleted. 2) In order to allow the user to clearly understand the results they can achieve if they use the device for a long term, the following words have been added: "The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.". The technical parameters of the subject device are similar to those of the predicate device. The results of the comparison show that the subject device can achieve this result.
Note3:The same models are totally same.
Note4:Though the wavelength of subject device is a little different from the predicate device, they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Note': Though the energy density and the output energy of subject device is a little different from the predicate devices, the energy density and the output energy of subject device is within the range of the maximum value of the predicate devices, and they all comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.
Note6:There is minor difference in spot size between the subject device and the predicate devices. The spot size is related to energy density and since the difference in energy density is not significant as explained in note5, so this difference will not raise any safety or effectiveness issue.
Note : Though the pulse duration of subject device is a little different from the predicate device, it's basically within the range of the predicate devices, and the subject device comply with IEC 60601-2-57/IEC 60601-2-83 and IEC 62471 requirement, so this difference will not raise any safety or effectiveness issue.
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7. Non-clinical studies and tests performed
Non-clinical tests have been conducted to verify that the Ice Cooling IPL Home Use Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device conforms to the following performance standards:
- A 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 A basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-1-6, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A 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
- A IEC 60601-2-57, Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic diagnostic monitoring and cosmetic/aesthetic use
- IEC 60601-2-83, Medical electrical equipment Part 2-83: Particular A requirements for the basic safety and essential performance of home light therapy equipment
-
IEC 62471, Photobiological safety of lamps and lamp systems
- IEC 62366-1, Medical devices Part 1: Application of usability engineering to > medical devices
The device has been tested for biocompatibility for conformance to the following performance standards:
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
-
ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
-
ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation
Software Verification and Validation
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Device Software Functions.
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8. Conclusion
Based on the above analysis, it can be concluded that the subject device Ice Cooling IPL Home Use Hair Removal Device meets the product requirements, which is based on the primary predicate device , and substantially equivalent to these predicate devices for permanent reduction in hair regrowth. Therefore, the modification resulted in a device that performs within the same specifications of the primary predicate device and the predicate devices, and is therefore substantially equivalent.