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.

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.

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.

AI/ML Overview

The provided text describes an IPL Hair Removal Device (K213558) and its substantial equivalence to predicate devices, but it does not include detailed information about an acceptance criteria table, device performance metrics, a study design (including sample sizes, ground truth establishment, or expert involvement), or comparative effectiveness studies (MRMC).

The document focuses on regulatory compliance, safety testing, and technological comparison to predicate devices rather than a performance study as typically understood for AI/algorithm-based devices.

Therefore, for most of your requested points, the information is not available in the provided text. I will provide what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The document lists "Specifications" for the device, which could be considered criteria, but it does not present a table of acceptance criteria with corresponding device performance results from a specific study.

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document discusses "lab bench testing" for safety and performance (referencing standards like IEC 60601-1) and a comparison to predicate devices based on technological characteristics. It does not describe a clinical performance study with a test set of data or human subjects to measure efficacy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no such performance study is described.

4. Adjudication Method for the Test Set
Not applicable, as no such performance study is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described. The document focuses on the device's technical specifications and safety compliance, not a clinical trial comparing human performance with and without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study is not described. This device is an IPL hair removal device, not an AI/software algorithm in the typical sense that would have "standalone performance" in data analysis. The "Software/Firmware/Microprocessor" is listed as "Yes" but no performance evaluation or study of this software is provided.

7. The Type of Ground Truth Used
Not applicable, as no performance study requiring a "ground truth" (like expert consensus, pathology, or outcomes data for diagnostic accuracy) is described. The device's "efficacy" is addressed by comparing its technological parameters (wavelength, fluence) to those of predicate devices, implying similar outcomes. The "Permanent hair reduction" definition mentions measurements at 6, 9, and 12 months, which are outcomes, but no study is detailed using these as ground truth.

8. The Sample Size for the Training Set
Not applicable, as no AI model training is described in the context of device performance, and no "training set" for such a purpose is mentioned.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as no AI model training or associated training set ground truth is described.

Summary of available information related to performance/efficacy:

Intended Use/Indications for Use: The IPL Hair Removal Device 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." It is also intended for "permanent reduction in unwanted hair."
Definition of Permanent Hair Reduction: "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."
Technological Comparison (indicating efficacy basis):
- Relies on the same Intense Pulsed Light (IPL) technology as predicate devices.
- Energy source: Xenon Arc Flashlamp (same as predicates).
- Wavelength of emitted light (spectrum): 550-1200nm (same as predicates).
- Fluence/flux: Delivers the same maximum energy (6 J/cm²) as predicate devices.
Safety and Performance Evaluation: Evaluated by "lab bench testing" according to standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization).
Conclusion: The subject device is deemed "substantially equivalent" to predicate devices, based on technological characteristics and the differences not raising new issues of safety or effectiveness.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K213558

Device Name IPL Hair Removal Device

Indications for Use (Describe)

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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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
Email	rd5@ulikebeauty.com
Application Correspondent
Company Name	PUREVISION AI, INC.
Address	111 Town Square Place, Ste 1203, Jersey City, NewJersey
Contact Person	Mr. Bryan Wong
Title	Associate
Telephone	+1 888 768 1688
Email	bryan@purefda.com

2. Subject Device Information

Trade Name	IPL Hair Removal Device
Classification Name	Powered Light Based Non-Laser Surgical InstrumentWith Thermal Effect
Review Panel	General & Plastic Surgery
Product Code	ONF

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Regulation Class 2

Requlation Number 878.4810

3. Predicate Device Information

Predicate device I - III:

Predicate Device	I	II	III
Sponsor	Kam Yuen PlasticProducts Ltd	CyDen Limited	SHASER, INC.
Device Name	Aimanfun LumeaComfort	iPulseSmoothSkin GoldHair RemovalSystem	SHASER V-MINIRX
510(k) Number	K190820	K160968	K132170
Product Code	ONF	OHT	ONF
RegulationNumber	878.4810	878.4810	878.4810
Regulation Class	2	2	2

4. Device Description

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.

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5. Intended Use / Indications for Use

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.

7. Materials

There is one part of patient directly contacting component in the subject device as the following list.

Component ofDevice requiringBiocompatibility	Material ofComponent	Body ContactCategory (ISO10993-1)	Contact Duration(ISO 10993-1)
Unit housing	ABS	Surface-contactingdevice: skin	Maximum 30minutes(< 24

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		hours)

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

Cytotoxicity
Sensitization
Irritation or intracutaneous reactivity

8. Physical characteristics

Basic Unit Characteristics
Main Unit Dimension	6038169.86mm
Unit housing material	ABS
Indicator	Indicates power information/skin detection information, energy level information.
Environment for operation	Temperature: 15-30°CHumidity: 10%-90%
Storage and Transport Conditions	Temperature: -10-60°CHumidity: 5%-90%
Compliance with Voluntary Standards	Yes. Comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.
Patient leakage current	Comply with IEC 60601-1
Power Source	Supplied by external adapter
Software/Firmware/Microprocessor	Yes
Control?
Specification

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Output Intensity Level	5 levels
Output energy	2-6J/cm²
Emitted Light Spectrum	550-1200nm
Pulse width range	0.54-3.00ms
Power Supply	External power
Technology	IPL

9. Test Summary

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.

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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff

10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of IPL Hair Removal Device, model: UI04A, UI04C is substantially equivalent to the predicate devices quoted above.

IPL Hair Removal Device relies on the same technology as both predicate devices: Intense Pulsed Light (IPL). Their energy source is the same: Xenon Arc Flashlamp.

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).

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Conclusion:

The subject device "IPL Hair Removal Device, Model: UI04A, UI04B, UI04C" is substantial equivalent to all predicate devices.

Regulation Number and Section

§ 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.