K Number
K223928
Device Name
Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Date Cleared
2023-03-28

(88 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Device Description
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). 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 a switch or auto light emission. Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal. The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
More Information

No
The description mentions a skin color sensor and a "Skin Color Recognition mode" which uses a "tone table" to determine if treatment is appropriate. This suggests a rule-based system or lookup table, not necessarily AI/ML. There is no mention of learning, adaptation, or complex pattern recognition typically associated with AI/ML in the provided text.

No.
A therapeutic device is used to treat a disease, injury, or other medical condition. This device is intended for the removal and permanent reduction of unwanted body hair, which is a cosmetic purpose and not a medical condition requiring treatment.

No

Explanation: The device is intended for hair removal and contains features like a skin color sensor and touch chip for safe operation during treatment, but its primary function is not to diagnose medical conditions or provide diagnostic information.

No

The device description clearly outlines physical components such as a Xenon arc flashlamp, touch chip, skin color sensor, main unit, adaptor, and goggles. It is a hardware device that utilizes IPL technology for hair removal.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Function: The provided description clearly states that this device is an Intense Pulsed Light (IPL) System intended for the removal of unwanted body hair. It works by applying light to the skin to reduce hair growth.
  • Lack of Sample Analysis: The device does not analyze any samples taken from the body. It interacts directly with the skin surface.

Therefore, based on the intended use and device description, this IPL system falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Product codes

OHT

Device Description

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). 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 a switch or auto light emission.

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

Principle of operation:
Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body

Indicated Patient Age Range

Adults aged over 18.

Intended User / Care Setting

Home use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

There was no clinical testing performed.

Key Metrics

Not Found

Predicate Device(s)

K220222

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 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

March 28, 2023

Shenzhen Fansizhe Science and Technology Co., Ltd % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China

Re: K223928

Trade/Device Name: Intense Pulsed Light (IPL) System, model: T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001A, T001N, T001N, T011C, T016K 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: December 29, 2022 Received: December 30, 2022

Dear You Yijie:

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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,

Jianting Wang -S

Jianting Wang Acting 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K223928

Device Name

Intense Pulsed Light (IPL) System, model:T023K, T023B, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K

Indications for Use (Describe)

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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:

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"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."

3

Section 5: 510(k) Summary

1. Submitters Information

Establishment Registration Information

Name:Shenzhen Fansizhe Science And Technology Co., Ltd
Address:2nd, 3rd And 4th Floors, No.11, Henggangxia Industrial
Zone, Xiangshan Community, Xinqiao Street, Bao'an
District, Shenzhen, Guangdong, China
Contact Person of applicant:
Name:Endang Cheng
Address:2nd, 3rd And 4th Floors, No.11, Henggangxia Industrial
Zone, Xiangshan Community, Xinqiao Street, Bao'an
District, Shenzhen, Guangdong, China
TEL:+86 18617061709
Email:ChengEndang1001@163.com
Contact Person of the Submission:
Name:You Yijie
Address:RM.406, Building C, Run Science Park, No.18
Shenzhou Road, Huangpu, Guangzhou, Guangdong
510663 P.R. China
TEL:(+86)020-82245821
FAX:(+86)020-82245821
Email:jet.you@qimmiq-med.com

Date prepared: Dec. 29, 2022

2. Device Information

Trade Name:Intense Pulsed Light (IPL) System
Model:T023K, T023A, T023B, T023C, T023D, T023E, T021K,
T021A, T001A, T001B, T001M, T001N, T011C, T016K
Classification name:Light Based Over-The-Counter Hair Removal
Common or Usual Name:Powered Light Based Non-Laser Surgical Instrument With
Thermal Effect
Review panel:General Plastic Surgery
Product code:OHT
Regulation Class:II
Regulation Number:878.4810

3. Predicate Device Information

510(k)Shenzhen Yuwei Electronic Technology Co., Ltd.
submitter/holder:

4

510(K) Number: K220222 Trade Name: IPL Hair Removal Device S1-A, S2-A, S1, S2, S3, S4 Model: Classification name: Light Based Over-The-Counter Hair Removal Review panel: General Plastic Surgery Product code: OHT Regulation Class: Regulation Number: 878.4810

4. Device description

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). 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 a switch or auto light emission.

Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

The device is intended to be used for adults aged over 18.

Principle of operation:

Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.

5

5. Indications for Use

The Intense Pulsed Light (IPL) System (Model: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K) is an over-the-counter device intended for the removal of unwanted body hair.

6. Summary of technological characteristics of device compared to the

predicate devices (K220222)

| SE
Comparisons | Subject device
(Intense Pulsed Light (IPL) System,
model: T023K, T023A, T023B, T023C,
T023D, T023E, T021K, T021A, T001A,
T001B, T001M, T001N, T011C, T016K) | Predicate device
(IPL Hair Removal Device, Model:
S1-A, S2-A, S1, S2, S3, S4) | Discussion of
difference |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 510K Number | / | K220222 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT | OHT | Same |
| FDA Class | II | II | Same |
| Indications for Use | The Intense Pulsed Light (IPL) System is
an over-the-counter device intended for
the removal of unwanted body hair. | IPL Hair Removal Device is an over-
the-counter device intended for
removal of unwanted body
hair. | Same |
| Model | T023K, T023A, T023B, T023C, T023D,
T023E, T021K, T021A, T001A, T001B,
T001M, T001N, T011C, T016K | S1-A, S2-A, S1, S2, S3, S4 | / |
| Environment of Use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Same |
| Material of Patient
contact
components | T023K, T023A: PC for button, PC for main
housing and Probe cover, Sapphire
Crystal Cooling Compress;
T023B, T023C: PC for button, PC for
main housing and Probe cover, Sapphire
Crystal Cooling Compress;
T023D, T023E: PC for button, PC for
main housing and Probe cover, Sapphire
Crystal Cooling Compress;
T021K, T021A: PC for button, PC for main
housing and Probe cover, Sapphire
Crystal Cooling Compress;
T001A, T001B, T001M, T001N: PC for
button, PC for main housing and Probe
cover;
T011C: PC for main housing, aluminum
for cold compress panel;
T016K: PC for button, PC for main
housing and Probe cover, Sapphire
Crystal Cooling Compress | ABS | Different
(Discussion is
indicated in
D1) |
| Biocompability
testing | 1.Type of contact: direct contact for
users and patients.
2.Nature of body contact category: | 1.Type of contact: direct contact for
users and patients.
2.Nature of body contact category: | Same |
| | Surface Contact class: A (