Who can help prepare an FDA 510(k) submission like Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

Q: Who is the manufacturer of Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

Shenzhen Mlay Intelligent Technology Co., , Ltd. filed the 510(k) submission for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) (K241106).

Q: What is the FDA product code for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

OHT. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

510(k) clearance (submission type: Special).

K241106 · Shenzhen Mlay Intelligent Technology Co., , Ltd. · OHT · May 22, 2024 · General, Plastic Surgery

Device Facts

Record ID	K241106
Device Name	Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
Applicant	Shenzhen Mlay Intelligent Technology Co., , Ltd.
Product Code	OHT · General, Plastic Surgery
Decision Date	May 22, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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 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.

Device Story

Personal, light-based hair reduction device for OTC home use. Inputs: user-selected energy level via finger switch. Operation: Xenon arc flashlamp emits Intense Pulsed Light (IPL) to target hair follicles; integrated cooling function (sapphire or aluminum alloy panel) cools skin during treatment. Safety: skin sensor prevents light emission unless fully contacted with skin. Output: light pulses for hair reduction. Benefits: non-invasive hair growth reduction with minimal pain. Healthcare provider role: none; patient self-operates. Clinical decision-making: patient follows treatment regime to achieve long-term hair regrowth reduction.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-57, 60601-2-83, 62471, and 62366-1. Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-23. Software verification and validation performed per FDA guidance.

Technological Characteristics

IPL hair removal device using Xenon arc flashlamp. Cooling panel materials: artificial sapphire or 5052 aluminum alloy. Energy density: 1.37-5.23 J/cm². Wavelength: 510-1200 nm. Pulse duration: 0.5-8.0 ms. Features: skin contact sensor, finger switch activation, 3-5 intensity levels. Electrical safety: IEC 60601-1 series. Biocompatibility: ISO 10993 series. Powered by external adapter.

Indications for Use

Indicated for removal of unwanted hair (underarm, facial below chin line, legs) and permanent reduction in hair regrowth in adults.

Regulatory Classification

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.

Predicate Devices

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) (K240264)
IPL Hair Removal Device (K223618)
IPL Hair Removal Device (K221002)
IPL Hair Removal Device Joy Version (K173813)

Submission Summary (Full Text)

{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) #### 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 - 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 | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ | 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 | {12}------------------------------------------------ | 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 | {13}------------------------------------------------ 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. {14}------------------------------------------------ ## 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…

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

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Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

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Predicate Devices

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