(70 days)
No
The description focuses on basic IPL technology, a skin sensor for contact detection, and standard electrical and safety compliance. There is no mention of AI, ML, image processing for analysis, or any data training/testing, which are typical indicators of AI/ML integration.
No
The device is intended for the cosmetic purpose of hair removal and reduction, not for treating or curing a disease or condition. While it is regulated as a medical device to ensure safety and effectiveness, its primary function is aesthetic.
No
The device is intended for hair removal, which is a cosmetic purpose, not for diagnosing any medical condition.
No
The device description clearly outlines hardware components such as a Xenon Quartz Lamp Tube, a skin sensor, and an external power adapter. While software verification and validation are mentioned, the device is fundamentally a hardware-based system utilizing Intense Pulsed Light 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The IPL HAIR REMOVAL HANDSET is a device that uses light energy applied directly to the skin to reduce hair growth. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanism of action (IPL technology applied to the skin) and safety features related to skin contact and light emission.
- Performance Studies: The performance studies mentioned are related to electrical safety, photobiological safety, biocompatibility, and software validation – all relevant to a device that interacts with the body externally, not one that analyzes biological samples.
Therefore, based on the provided information, the IPL HAIR REMOVAL HANDSET is a medical device, but it falls under a different category than In Vitro Diagnostics. It is likely classified as a therapeutic or aesthetic device.
N/A
Intended Use / Indications for Use
IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The IPL HAIR REMOVAL HANDSET 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair. Specifically, 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 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)
Non-clinical testings have been conducted to verify that the IPL HAIR REMOVAL HANDSET 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 complies with the following 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
- A IEC 60601-1-11, Medical electrical equipment - Part 1-11: 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 60601-2-83, 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, it complies with the following standards.
- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for InVitro A Cvtotoxicitv
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance A for Pre Market Submissions and for Software Contained in Medical Devices"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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".
May 16, 2022
Shenzhen Junbobeauty Technology Co., Ltd. % Tracy Che Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K220669
Trade/Device Name: IPL HAIR REMOVAL HANDSET, Model: IPL-666 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: February 25, 2022 Received: March 7, 2022
Dear Tracy Che:
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) K220669
Device Name IPL HAIR REMOVAL HANDSET, Model: IPL-666
Indications for Use (Describe)
IPL HAIR REMOVAL HANDSET 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 Junbobeauty Technology Co., Ltd. |
|---|---|
| Address: | #522, Jinyuan Business Building A, Xixiang Blvd 300, Bao'an District, Shenzhen |
| Contact person: | Jian Zhan |
| Phone number: | +86 17665318870 |
| Fax number: | / |
| Email: | 779182481@qq.com |
| Date of summary prepared: | 2022-2-25 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | IPL HAIR REMOVAL HANDSET, Model: IPL-666 |
|---|---|
| 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 |
(4) Predicate and reference device
> Predicate device
| Sponsor | Medical Device Branch of Zhangzhou Easepal Industrial
Co.,Ltd. |
|-----------------------|-------------------------------------------------------------------|
| Device Name and Model | IPL Salon Hair Reduction System, Model: F60001 |
| 510(k) Number | K181568 |
| Product Code | OHT |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
| > Reference device | |
| Sponsor | Shenzhen Bosidin Technology Co. Ltd. |
| Device Name and Model | IPL Home Use Hair Removal Device |
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K220669
Shenzhen Junbobeauty Technology Co., Ltd. 510(k)s - Section 8. 510 (k) Summary
| 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 |
(5) Description/ Design of device:
The IPL HAIR REMOVAL HANDSET 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 HANDSET includes only one model IPL-666.
(6) Indications for use:
IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair.
(7) Materials
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL HAIR | |||
| REMOVAL | |||
| HANDSET | |||
| (Enclosure | |||
| and flash | |||
| window) | Plastic, metal | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence:
| Item | Subject device | Predicate device | Reference device | Remark |
|---|---|---|---|---|
| Trade name | IPL HAIR REMOVAL | |||
| HANDSET | ||||
| Model: IPL-666 | IPL Salon Hair | |||
| Reduction System, | ||||
| Model: F60001 | IPL Home Use Hair | |||
| Removal Device | ||||
| Model(s): D-1128, | / | |||
| 510 (k) number | Applying | K181568 | D-1103, D-1119, | |
| D-1129, D-1130 | ||||
| K192432 | / | |||
| Manufacturer | Shenzhen Junbobeauty | |||
| Technology Co., Ltd. | Medical Device | |||
| Branch of Zhangzhou | ||||
| Easepal Industrial | ||||
| Co., Ltd. | Shenzhen Bosidin | |||
| 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 | |||
| HANDSET is an over- | ||||
| the-counter device | ||||
| intended for removal of | ||||
| unwanted body and/or | ||||
| facial hair. | The IPL Salon Hair | |||
| Reduction System | ||||
| (Model: F60001) is an | ||||
| over the Counter | ||||
| device intended for | ||||
| the removal of | ||||
| unwanted body and/or | ||||
| facial hair in adults. It | ||||
| 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 | ||||
| re-growing when | ||||
| measured at 6. 9. and | ||||
| 12 months after the | ||||
| completion of a | ||||
| treatment regimen. | IPL Home Use Hair | |||
| Removal Device 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 | Unknown | Fitzpatrick Skin | ||
| Phototypes I-V | Same | |||
| Treatment area | Used on facial hair | |||
| below the chin line, | ||||
| arms, legs, underarms, | ||||
| bikini line. | The device is | |||
| designed for use on | ||||
| the legs, underarms, | ||||
| bikini line, chest, | ||||
| stomach, back, arms | ||||
| and on the face below | ||||
| the cheekbones | 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. | Similar | |||
| Device design | ||||
| Power source | An external power supply | Supplied by external adapter | Supplied by external power adapter | Same |
| Power supply | 100~240V AC Input 12V3A DC Output | 100-240 V AC; 50/60 Hz | Input: 100-240V 50/60Hz 1.0-0.5A | |
| Output: DC12V 3A | Different | |||
| Note 1 | ||||
| Product compositions | IPL Hair Removal Handset and power adapter | Device includes a treatment window head, a facial adaptor and battery charger/ AC cord. | IPL host, lamp cartridge and power adapter | Similar |
| Structure design | Handheld | Handheld | Handheld | Same |
| Dimension | 1248348.5mm | 143 x69.5 x 43mm (HWD) | 218 x 144 x 60mm | Different |
| Note 2 | ||||
| Weight | 186g | 650g | 355g | 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 Quartz Tube | Xenon Arc Flashlamp | Xenon lamp | Similar |
| Note 3 | ||||
| Wavelength range (nm) | 470nm ~1100nm | 475nm~1200nm | Regular window: 510 ~ 1100nm | |
| Filter window: 600 ~ 1100nm | Similar | |||
| Note 3 | ||||
| Energy density (J/cm²) | Max 2.49J/cm² | Max 5J/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) | Similar | |||
| Note 3 | ||||
| Spot size (Size of treatment window) (cm²) | 3cm² | 1.72 cm² or 3.02 cm² | Regular window: 4.5cm², 2.0cm², 3.0cm² | |
| Filter window: 2.5cm² | Same | |||
| Pulse duration | 11.5-15ms | 11-12ms | 7.5-14ms | 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 levels | 5 levels | 5 levels | Same |
| intensity level | ||||
| Skin sensor | Sensor fixed in handset | |||
| and can be moved to | ||||
| treatment part | Sensor fixed in device | |||
| and can be moved to | ||||
| treatment part | Sensor fixed in device | |||
| and can be moved to | ||||
| treatment part | Same | |||
| Software/ | ||||
| Firmware/ | ||||
| Microprocessor | ||||
| Control? | Yes | Yes | Yes | Same |
| Additional features | ||||
| Skin-contacting | ||||
| components | Plastic enclosure and | |||
| treatment window | IPL Lamp output | |||
| window | Plastic enclosure and | |||
| treatment window | Same | |||
| Materials of | ||||
| skin-contacting | ||||
| components | Plastic, metal | ABS | ABS, PC, Aluminium | |
| alloy | Different | |||
| Note 4 | ||||
| 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 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC60601-2-57 | IEC60601-1-2 | |||
| IEC60601-1 | ||||
| IEC60601-1-11 | ||||
| IEC60601-2-57 | Similar | |||
| Photobiological | ||||
| safety | IEC62471 | Unknown | IEC62471 | Same |
5
6
K220669
Shenzhen Junbobeauty Technology Co., Ltd.
510(k)s – Section 8. 510 (k) Summary
7
Shenzhen Junbobeauty Technology Co., Ltd. 510(k)s - Section 8. 510 (k) Summary
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, although they are a little different, the output specification such as wavelength range, energy density, pulse duration are close to the predicate's device range, these parameters of the subject device can be basically covered by the predicate devices' range, they are very similar. So this difference will not raise any safety/ effectiveness problems.
Note 4:
Although the "Materials of skin-contacting components" of the subject device and predicate device are not exactly the same, the skin-contacting components of the subject device has been tested and satisfied the standard requirements of ISO 10993-1. So this difference will not raise any safety/ effectiveness problems.
8
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the IPL HAIR REMOVAL HANDSET 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 complies with the following 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
- A IEC 60601-1-11, Medical electrical equipment - Part 1-11: 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 60601-2-83, 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, it complies with the following standards.
- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for InVitro A Cvtotoxicitv
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA "Guidance A for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL HAIR REMOVAL HANDSET is as safe, as effective, and performs as well as the legally marketed predicate device, IPL Salon Hair Reduction System.