(86 days)
No
The description focuses on basic IPL technology, a skin sensor for contact detection, and standard electrical/biocompatibility testing. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration. The software validation mentioned is standard for medical devices and doesn't specifically indicate AI/ML.
Yes
The device is intended for removal of unwanted body and/or facial hair, which is a cosmetic procedure for hair reduction and not a therapeutic function for treating a disease or condition. However, medical devices are broadly categorized as therapeutic devices if they perform a function impacting the body, regardless of whether it's for disease treatment or cosmetic purposes. In this case, hair removal is a body function that is impacted.
No
The device is an IPL hair removal device intended for cosmetic hair reduction, not for diagnosing medical conditions.
No
The device description explicitly details hardware components such as a Xenon Quartz Lamp Tube, skin sensor, and external power adapter. It also mentions physical dimensions and treatment area (spot size), which are hardware characteristics. While software verification and validation are mentioned, the device is clearly a physical device with embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "removal of unwanted body and/or facial hair." This is a cosmetic or therapeutic purpose, not a diagnostic one.
- Device Description: The description details a light-based device for hair reduction, working on the skin's surface. This aligns with a physical treatment device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a person's health status, disease, or condition. IVDs are designed to perform tests on these types of samples to aid in diagnosis, monitoring, or screening.
The device is clearly described as a personal, over-the-counter device for hair removal, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes
OHT
Device Description
The IPL 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 (IPL) technology. 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 Quartz Lamp Tube to emit light and a skin sensor 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 trigger a pulse emitting.
The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair. Used on facial hair below the chin line, arms, legs, underarms, bikini line.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter device directly to the end user.
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)
Non-clinical testings have been conducted to verify that the IPL Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device conforms to the following performance standards:
- ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General requirements for A basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic A safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-83, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471, Photobiological safety of lamps and lamp systems
The device has been tested for biocompatibility for conformance to the following performance standards:
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and A Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 31, 2023
Shenzhen Yangyi Technology., Ltd % Bing Huang Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K230021
Trade/Device Name: IPL Hair Removal Device, Model(s): AP10, AP20, AP32 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: January 4, 2023 Received: January 4, 2023
Dear Bing Huang:
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
Indications for Use
510(k) Number (if known) K230021
Device Name
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
Indications for Use (Describe)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial 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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Shenzhen Yangyi Technology Co., Ltd. |
|---|---|
| Address: | Third Floor South, NO. 201, Building A8, Hua Fa |
| Industrial Area, Fuyuan 1st Road, ZhanCheng Community, | |
| Fuhai Street, Bao'an District, Shenzhen, City |
| Contact person: | Wang Jie |
|---|---|
| Phone number: | +86 17837655793 |
| Fax number: | / |
| Email: | 971679079@qq.com |
| Date of summary prepared: | 2023-3-27 |
(2) Proprietary name of the device
| Trade name/model: | IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 |
|---|---|
| Common name: | Light Based Over-The-Counter Hair Removal |
| Regulation number: | 21 CFR 878.4810 |
| Product code: | OHT |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(3) Predicate and reference device
| ➤ Predicate device | |
|---|---|
| Sponsor | Shenzhen Bosidin Technology Co., Ltd |
| Device Name and Model | IPL Home Use Hair Removal Device |
| Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 | |
| 510(k) Number | K192432 |
| Product Code | OHT |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
| ➤ Reference device | |
| Sponsor | Shenzhen Junbobeauty Technology Co., Ltd |
| Device Name and Model | IPL HAIR REMOVAL HANDSET, |
Model: IPL-666
4
Shenzhen Yangyi Technology Co., Ltd. 510(k)s - Section 8. 510 (k) Summary
| 510(k) Number | K220669 |
|---|---|
| Product Code | OHT |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
(4) Description/ Design of device:
The IPL 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 (IPL) technology. 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 Quartz Lamp Tube to emit light and a skin sensor 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 trigger a pulse emitting.
The IPL Hair Removal Device includes: AP10, AP20, AP32 four models. Their intended use, performance, structure design and operation, are essential the same for the device models, with main differences being product appearance, display contents, physical product dimension, treatment area (spot size), output energy and power supply.
(5) Indications for use:
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Hair | |||
| Removal | |||
| Device | |||
| (Enclosure | |||
| and | |||
| light-emitting | |||
| window) | ABS+PC | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
(6) Materials
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
| Item | Subject device | Predicate device | Reference device | Remark |
|---|---|---|---|---|
| Trade name | / | |||
| IPL Hair Removal | ||||
| Device | ||||
| Model(s): AP10, AP20, AP30, AP32 | IPL Home Use Hair | |||
| Removal Device | ||||
| Model: D-1128, D-1103, D-1119, D-1129,D-1130 | IPL HAIR REMOVAL | |||
| HANDSET | ||||
| Model: IPL-666 | / | |||
| 510 (k) number | Applying | K192432 | K220669 | / |
| Manufacturer | Shenzhen Yangyi | |||
| Technology Co., Ltd. | Shenzhen Bosidin | |||
| Technology Co., Ltd. | Shenzhen Junbobeauty | |||
| Technology Co., Ltd. | / | |||
| Regulation | ||||
| number | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Class | II | II | II | Same |
| Indications for | ||||
| use/ Intended | ||||
| use | IPL Hair Removal | |||
| Device is an over-the-counter | ||||
| device intended for removal of | ||||
| unwanted body and/or | ||||
| facial hair. | IPL Home Use Hair | |||
| Removal Device is an | ||||
| over-the-counter | ||||
| device intended for | ||||
| removal of unwanted | ||||
| body and/or facial | ||||
| hair. | IPL HAIR REMOVAL | |||
| HANDSET is an | ||||
| over-the-counter device | ||||
| intended for removal of | ||||
| unwanted body and/or | ||||
| facial hair. | Same | |||
| Prescription or | ||||
| OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick Skin | |||
| Phototypes I-V | Fitzpatrick Skin | |||
| Phototypes I-V | Fitzpatrick Skin | |||
| Phototypes I-V | Same | |||
| Treatment area | Used on facial hair | |||
| below the chin line, | ||||
| arms, legs, underarms, | ||||
| bikini line. | Removal of unwanted | |||
| body 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. | Used on facial hair | |||
| below the chin line, | ||||
| arms, legs, underarms, | ||||
| bikini line. | Similar | |||
| Device design | ||||
| Power source | An external power | |||
| supply | Supplied by external | |||
| adapter | An external power | |||
| supply | Same | |||
| Power supply | Input: 100~240V AC | |||
| Output: | ||||
| AP10: 24V3A DC; | ||||
| AP20, AP30, AP20: | ||||
| 12V4A DC | Input: 100-240V | |||
| 50/60Hz 1.0-0.5A | ||||
| Output: DC12V 3A | 100~240V AC Input | |||
| 12V3A DC Output | Different | |||
| Note 1 | ||||
| Product | ||||
| compositions | IPL host and power | |||
| adapter | IPL host, lamp | |||
| cartridge and power | ||||
| adapter | IPL Hair Removal | |||
| Handset and power | ||||
| adapter | Similar | |||
| Structure | Handheld | Handheld | Handheld | Same |
| design | ||||
| Dimension | AP10: 20118480mm | |||
| AP20: 20916178mm | ||||
| AP30: 1666240mm | ||||
| AP32: 1676341mm | D-1128: | |||
| 21811460mm | ||||
| D-1129: | ||||
| 20713763mm | ||||
| D-1103: | ||||
| 20713763mm | ||||
| D-1119: | ||||
| 19814183mm | ||||
| D-1130:21214164 mm | 1248348.5mm | Different | ||
| Note 2 | ||||
| Weight | AP10: 451g | |||
| AP20: 421g | ||||
| AP30: 320g | ||||
| AP32:320g | D-1128: 355g | |||
| D-1129:340g | ||||
| D-1103:365g | ||||
| D-1119:370g | ||||
| D-1130:340g | 186g | Different | ||
| Note 2 | ||||
| Sterilization | Not required | Not required | Not required | Same |
| Output specification | ||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Quartz Tube | Same |
| Wavelength range (nm) | 530nm~1100nm | Regular window: 510 ~ 1100nm | ||
| Filter window: 600 ~ 1100nm | 470nm~1100nm | Similar | ||
| Note 3 | ||||
| Energy density (J/cm²) | Max 4.3J/cm² | 2.0~4.0J/cm² | ||
| (applicable for model D-1128, D-1119, D-1129, D-1130) | ||||
| 2.5~4.5J/cm² | ||||
| (applicable for model D-1103) | Max 2.49 J/cm² | Similar | ||
| Note 3 | ||||
| Spot size (Size of treatment window) (cm²) | 3.3 cm², 3.96 cm²,3.63 cm² | Regular window: 4.5cm², 2.0cm², 3.0cm² | ||
| Filter window: 2.5cm² | 3 cm² | Similar | ||
| Note 4 | ||||
| Pulse duration | 8.8~13.2ms | 7.5~14ms | 11.5~15ms | Similar |
| Note 3 | ||||
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Number of output channels | One channel | One channel | One channel | Same |
| Output | 5 | 5 | 5 | Similar |
| intensity level | (applicable for model | |||
| AP10, AP30, AP32) | ||||
| 9(applicable for model | ||||
| AP20) | Note 5 | |||
| Skin sensor | Sensor fixed in host and | |||
| can be moved to | ||||
| treatment part | Sensor fixed in device | |||
| and can be moved to | ||||
| treatment part | Sensor fixed in handset | |||
| and can be moved to | ||||
| treatment part | Same | |||
| Software/ | ||||
| Firmware/ | ||||
| Microprocessor | ||||
| Control? | Yes | Yes | Yes | Same |
| Additional features | ||||
| Skin-contacting | ||||
| components | Plastic enclosure and | |||
| light-emitting window | Plastic enclosure and | |||
| treatment window | Plastic enclosure and | |||
| treatment window | Same | |||
| Biocompatibility | All user directly | |||
| contacting materials are | ||||
| compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | All user directly | |||
| contacting materials | ||||
| are compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | All user directly | |||
| contacting materials are | ||||
| compliance with | ||||
| ISO10993-5 and | ||||
| ISO10993-10 | ||||
| requirements. | Same | |||
| Electrical | ||||
| safety | IEC60601-1-2 | |||
| IEC60601-1 | ||||
| IEC60601-1-11 | ||||
| IEC60601-2-83 | IEC60601-1-2 | |||
| IEC60601-1 | ||||
| IEC60601-1-11 | ||||
| IEC60601-2-57 | IEC60601-1-2 | |||
| IEC60601-1 | ||||
| IEC60601-1-11 | ||||
| IEC60601-2-83 | Same | |||
| Photobiological | ||||
| safety | IEC62471 | IEC62471 | IEC62471 | Same |
5
6
7
Comparison in details:
Note 1:
The power adapter has been tested along with the subject device for electrical safety, so this difference will not raise any safety/effectiveness problems.
Note 2:
Although the appearance, weight and dimensions are different between the subject and predicate device, these differences are insignificant and do not raise any safety/effectiveness problems.
Note 3:
The energy medium are both Xenon lamp, the output specification such as wavelength range, energy density, pulse duration are close to the predicate and reference device's range, these parameters of the subject device can be basically covered by the predicate and reference devices' range, they are very similar. So this difference will not raise any safety/effectiveness problems.
Note 4:
Although there are differences between subject device models spot sizes compared to the predicate device, the energy density and other light output characteristics are sufficiently similar so that the treatment window size differences do not raise safety/effectiveness concerns when the device is used properly.
8
Note 5:
The model AP20 has nine different output levels, but the energy density range of this subject device mode is similar to the predicate device range.
(8) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the IPL Hair Removal Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device conforms to the following performance standards:
- ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General requirements for A basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic A safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
IEC 60601-2-83, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471, Photobiological safety of lamps and lamp systems >
The device has been tested for biocompatibility for conformance to the following performance standards:
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and A Skin Sensitization.
We have also conducted:
-
Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
(9) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device, IPL Home Use Hair Removal Device.