(120 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on IPL technology and a skin proximity sensor, with no mention of AI/ML capabilities.
Yes.
The device is intended for "patient removal of unwanted hair by using a selective photothermal treatment" and "permanent reduction in unwanted hair," which are therapeutic applications. It is also explicitly deemed to meet "Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use" in the IEC 60601-2-57 standard.
No
Explanation: The device is an IPL hair removal device, intended for therapeutic and cosmetic use (hair removal), not for diagnosing a condition or disease.
No
The device description clearly outlines physical hardware components such as a Xenon Lamp, a skin proximity sensor, and specific dimensions (6038169.86mm). It also mentions using IPL technology, which is a light-based physical treatment. The performance studies listed are for electrical and biological safety of a physical device, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device works by applying light energy directly to the skin to target hair follicles. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for hair removal and permanent hair reduction, which is a cosmetic/aesthetic procedure, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the light technology and its application to the skin, not on analyzing biological samples.
- Performance Studies: The performance studies listed are related to electrical safety, electromagnetic compatibility, home healthcare environment use, and biological evaluation (cytotoxicity and skin sensitization), which are typical for devices that interact directly with the body, not for IVDs that analyze samples.
Therefore, the IPL Hair Removal Device described is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair.
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
Product codes
ONF
Device Description
IPL Hair Removal Device, Model: UI04A, UI04B, UI04C, is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment.
The size of the device is about 6038169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarms, bikini line, arms and legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
under the direction of a physician, after training by a healthcare professional.
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)
IPL Hair Removal Device, Model: UI04A has been evaluated the safety and performance by lab bench testing as following:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012
IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 2014
IEC 60601-1-11:2015 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57:2011 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:
· Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. IPL Hair Removal Device and the predicate devices utilize the same spectrum(550-1200nm).
• Fluence/flux – defines the energy per area (e.g. joules per cm²) for the treatment. IPL Hair Removal Device and the predicate devices deliver the same maximum energy (6 J/cm2).
Predicate Device(s)
Reference Device(s)
Not Found
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.
March 8, 2022
Ulike Co., Ltd % Bryan Wong Associate, RAC PureVision Ai, Inc. 111 Town Square Place. Suite 1203 Jersey City, New Jersey 07310
Re: K213558
Trade/Device Name: IPL Hair Removal Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF Dated: November 8, 2021 Received: November 8, 2021
Dear Bryan Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Purva Pandya 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
2
Indications for Use
510(k) Number (if known) K213558
Device Name IPL Hair Removal Device
Indications for Use (Describe)
The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair.
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
| Sponsor | |
|---|---|
| Company Name | Ulike Co., Ltd |
| Address | 2, Myeongdong, 6-gil, Jung-gu, Seoul, Korea |
| Contact Person | Ms. Lin Xiaoming |
| Title | Quality Manager |
| rd5@ulikebeauty.com | |
| Application Correspondent | |
| Company Name | PUREVISION AI, INC. |
| Address | 111 Town Square Place, Ste 1203, Jersey City, New |
| Jersey | |
| Contact Person | Mr. Bryan Wong |
| Title | Associate |
| Telephone | +1 888 768 1688 |
| bryan@purefda.com |
2. Subject Device Information
| Trade Name | IPL Hair Removal Device |
|---|---|
| Classification Name | Powered Light Based Non-Laser Surgical Instrument |
| With Thermal Effect | |
| Review Panel | General & Plastic Surgery |
| Product Code | ONF |
4
Regulation Class 2
Requlation Number 878.4810
3. Predicate Device Information
Predicate device I - III:
| Predicate Device | I | II | III |
|---|---|---|---|
| Sponsor | Kam Yuen Plastic | ||
| Products Ltd | CyDen Limited | SHASER, INC. | |
| Device Name | Aimanfun Lumea | ||
| Comfort | iPulse | ||
| SmoothSkin Gold | |||
| Hair Removal | |||
| System | SHASER V-MINI | ||
| RX | |||
| 510(k) Number | K190820 | K160968 | K132170 |
| Product Code | ONF | OHT | ONF |
| Regulation | |||
| Number | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 | 2 |
4. Device Description
IPL Hair Removal Device, Model: UI04A, UI04B, UI04C, is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology can achieve long-term hair removal results at a fraction of the energy level used in other light -based hair removal equipment.
The size of the device is about 6038169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
5
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
5. Intended Use / Indications for Use
The IPL Hair Removal Device (Model: U104A, U104C) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The IPL Hair Removal Device is also intended for permanent reduction in unwanted hair.
6. Design
IPL Hair Removal Device consists of main unit and adaptor. It is a portable device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL) which is a xenon lamp.
The size of the device is about 6038169.86mm (W x D x H). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered to emit a pulse.
7. Materials
There is one part of patient directly contacting component in the subject device as the following list.
| Component of
Device requiring
Biocompatibility | Material of
Component | Body Contact
Category (ISO
10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Unit housing | ABS | Surface-contacting
device: skin | Maximum 30
minutes(