(59 days)
No
The description details standard IPL technology with sensors for skin contact and color detection, but there is no mention of AI or ML algorithms for processing data, making decisions, or adapting the treatment. The skin color detection appears to be a simple threshold check against a predefined table.
No.
The device is intended for the removal of unwanted body hair, which is a cosmetic purpose, not a therapeutic one. It does not treat or prevent any disease, injury, or medical condition.
No
The device is an IPL hair removal device, designed for the physical removal or reduction of unwanted hair, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a Xenon arc flashlamp, built-in battery, capacitive sensor, and skin color sensor, all of which are integral to the device's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal device works by applying light energy to the skin to target hair follicles and reduce hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the removal of unwanted body hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The device operates externally on the body and its function is related to physical interaction with the skin and hair, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.
Product codes
OHT
Device Description
IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the 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 powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission.
IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable 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. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, 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, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, 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 IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins.
When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor.
When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.
The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
There was no clinical testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 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".
June 26, 2023
ZhongShan Qizhe Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangdong, Guangdong 510663 China
Re: K231215
Trade/Device Name: IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S 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 20, 2023 Received: April 28, 2023
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)
Device Name
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL008S
Indications for Use (Describe)
The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) 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)
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3
510(k) Summary
K231215
1. Submitters Information
Establishment Registration Information
| Name: | Zhongshan Qizhe Technology Co., Ltd |
|---|---|
| Address: | 23 Tongji West Road, Nantou Town, Zhongshan City |
| (Room 902, Building 8, Hongji Industrial City Phase II) |
Contact Person of applicant:
| Name: | Gan Guiping |
|---|---|
| Address: | 23 Tongji West Road,Nantou Town,Zhongshan City |
| (Room 902, Building 8, Hongji Industrial City Phase II) | |
| TEL: | +86 13902957808 |
| Email: | peter@r-d.com.cn |
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 of the summary prepared: Jun. 15, 2023
2. Device Information
| Trade Name: | IPL Hair Removal device |
|---|---|
| Model: | Skin Expert Pro IPL 008 |
| Skin Expert Pro IPL 008S | |
| 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
4
Primary Predicate Device 1
| 510(k) submitter/holder: | Touchbeauty Beauty & Health
(Shenzhen) Co., Ltd |
|--------------------------|----------------------------------------------------|
| 510(K) Number: | K183217 |
| Trade Name | IPL Hair Removal Device |
| Model | TB-1755 |
| Classification name | Light Based Over-The-Counter Hair
Removal |
| Review panel | General & Plastic Surgery |
| Product code | OHT, ONF |
| Regulation Class | II |
| Regulation Number | 878.4810 |
Primary Predicate Device 2
| 510(k) submitter/holder: | Shenzhen Fansizhe Science and
Technology Co., Ltd |
|--------------------------|-------------------------------------------------------------------------------------------|
| 510(K) Number: | K223928 |
| Trade Name | IPL Hair Removal Device |
| Model | T016K |
| Classification name | Laser Surgical Instrument For Use In
General And Plastic Surgery And In
Dermatology |
| Review panel | General & Plastic Surgery |
| Product code | OHT |
| Regulation Class | II |
| Regulation Number | 878.4810 |
4. Device description
IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the 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 powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission.
IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable 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. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, 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.
5
Based on the cooling technology, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, 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 IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins.
When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor.
When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again.
The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver.
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. Indications for Use
IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is an Overthe Counter device intended for the removal of unwanted body hair.
6
6. Summary of technological characteristics of device compared to the predicate device1 (K183217) and
predicate device2(K160968)
| SE
Comparisons | Subject device
(IPL Hair Removal device,
model: Skin Expert Pro IPL 008,
Skin Expert Pro IPL 008S) | Predicate device 1
(IPL Hair Removal Device, Model:
TB-1755) | Predicate device 2
(IPL Hair Removal Device, Model:
T016K) | Discussion of
difference |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510K Number | / | K183217 | K223928 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT | OHT, ONF | OHT | Same |
| FDA Class | II | II | II | Same |
| Indications for Use | The IPL Hair Removal device(model:
Skin Expert Pro IPL 008, Skin Expert
Pro IPL 008S) is an Over the Counter
device intended for the removal of
unwanted body hair. | The IPL Hair Removal device (model:
TB-1755) is an Over the Counter
device intended for the removal of
unwanted body hair. | The IPL Hair Removal Device is an
over-the-counter device intended for
the removal of unwanted body hair. | Same |
| Environment of Use | Home use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Adult | Same |
| Material of Patient
contact components | ABS for button, ABS for main housing,
PC for Probe cover, PC for Light Exit
Window, PC for Touch key-press ,
Sapphire Crystal Cooling Compress | Not public | PC for button, PC for main housing
and Probe cover, Sapphire Crystal
Cooling Compress | Different
(Discussion is
indicated in D1) |
| Biocompability testing | 1.Type of contact: direct contact for
users and patients.
2.Nature of body contact category:
Surface Contact class: A (