(83 days)
No
The device description and performance studies focus on standard electrical, safety, and usability testing, with no mention of AI/ML algorithms or data processing beyond a simple skin contact sensor.
No.
The device is intended for cosmetic hair reduction, not for diagnosing, treating, or preventing a disease or condition.
No
The device is intended for hair removal, a cosmetic application, and does not diagnose any medical condition or disease.
No
The device description explicitly details hardware components such as an external power adapter, finger switch, skin sensor, and light outlet, and the performance studies include testing for electrical safety and biocompatibility, indicating it is a physical device with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of unwanted body and/or facial hair. This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Mechanism of Action: The device uses Intense Pulsed Light (IPL) to reduce hair growth. This is a physical interaction with the body (specifically hair follicles), not an analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Device Description: The description focuses on the physical aspects of the device and its function in emitting light for hair reduction. There is no mention of analyzing or testing biological samples.
- Anatomical Site: The anatomical site is body and/or facial hair, which is the target of the treatment, not the source of a diagnostic sample.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of analytes (substances in the body).
- Diagnosis, monitoring, or prognosis of diseases or conditions.
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating diagnostic accuracy.
In summary, the IPL Hair Removal Device is a therapeutic or aesthetic device that uses light energy to reduce hair growth. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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
IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using 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 (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Not Found. The predicate device mentions "adults".
Intended User / Care Setting
over-the-counter, home-use and personal device
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 tests were 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 and reference devices. The test results demonstrated that the subject device complies with the following standards:
- Biocompatibility Testing:
- ISO 10993-5:2009, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and EMC:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems
- Software Verification and Validation:
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- Usability:
- The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 6, 2023
Shenzhen BSX Technology Electronics Co., Ltd. % Riley Chen 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: K230097
Trade/Device Name: IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 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 28, 2022 Received: January 13, 2023
Dear Riley Chen:
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.
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
1
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,
Colin K. Chen -S
for
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)
Device Name IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
Indications for Use (Describe)
The 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
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Shenzhen BSX Technology Electronics Co., Ltd.
Rm101&2/F~4/F, Building No.13, Ailian Industrial Park, Wulian Community, LongGang District, ShenZhen, 518116, GuangDong, P.R. China. Tel .: +86-0755-28719103
Hong Li Regulation Assistant Tel: +86 18133439986 Email: 1013540630@qq.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device
Primary predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Medical Device Branch of | |||
| Zhangzhou Easepal | |||
| Industrial Co.,Ltd. | IPL Salon Hair Reduction | ||
| System (Model: F60001) | K181568 | Sep. 11, 2018 |
Reference devices:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Junbobeauty | |||
| Technology Co., Ltd. | IPL HAIR REMOVAL | ||
| HANDSET, Model: IPL-666 | K220669 | May 16, 2022 | |
| Shenzhen Leaflife | |||
| Technology Co., Ltd | Leaf Smooth | K212697 | Nov. 19, 2021 |
IV. Device Description
IPL Hair Removal Device (Model: BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108), is an over-the-counter, home-use and personal device for hair reduction by using
4
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 (a.c.100~240V 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the Light Outlet of the device is not in full contact with the skin, the device cannot trigger a light pulse. The device have six models and these models share the same performance, structure and operation, the only difference is their enclosure color.
V. Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair.
VI. Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Hair Removal Device | ABS | 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 Section 16 "Biocompatibility Discussion".
VII. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intended use as the predicate and reference devices. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate device and reference devices. Any minor differences between the subject device and the listed predicate device and reference devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference devices.
| Comparison
| Elements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Remark |
|---|---|---|---|---|---|
| 510(k) | |||||
| Number | Pending | K181568 | K220669 | K212697 | / |
| Trade name | IPL Hair Removal | ||||
| Device | IPL Salon Hair | ||||
| Reduction System, | |||||
| Model: F60001 | IPL | ||||
| HAIR | |||||
| REMOVAL | |||||
| HANDSET | |||||
| Model: IPL-666 | Leaf Smooth | / | |||
| Manufacturer | Shenzhen | ||||
| Technology | |||||
| Electronics Co., Ltd. | BSX Medical Device Branch | ||||
| of Zhangzhou Easepal | |||||
| Industrial Co.,Ltd. | Shenzhen | ||||
| Junbobeauty | |||||
| Technology Co., Ltd. | Shenzhen Leaflife | ||||
| Technology Co., Ltd | / | ||||
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Comparison | |||||
| Elements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Remark |
| number | |||||
| Product code | OHT | OHT | OHT | OHT | Same |
| Device | |||||
| classification | Class II | Class II | Class II | Class II | Same |
| Indication for | |||||
| use/ Intended | |||||
| use | The IPL Hair | ||||
| Removal Device 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 numberof hairs re-growing | |||||
| when measured at 6. 9. | |||||
| and 12 months after the | |||||
| completion of a | |||||
| treatment regimen. | IPL HAIR | ||||
| REMOVAL | |||||
| HANDSET is an | |||||
| over-the-counter | |||||
| device intended for | |||||
| removal of unwanted | |||||
| body and/or facial | |||||
| hair. | The Leaf Smooth is | ||||
| an over-the-counter | |||||
| device intended for | |||||
| removal of | |||||
| unwanted body | |||||
| and/or facial hair. | Same | ||||
| Prescription | |||||
| or OTC | OTC | OTC | OTC | OTC | Same |
| Applicable | |||||
| skin | Fitzpatrick Skin | ||||
| Types I-V | / | Fitzpatrick Skin | |||
| Types I-V | / | Same | |||
| Device design | |||||
| Source | |||||
| energy | Supplied by external | ||||
| adapter | Supplied by external | ||||
| adapter | Powered by external | ||||
| power adapter | Supplied by | ||||
| external adapter | Same | ||||
| Power supply | 100-240V, 50/60Hz | 100-240V AC; 50/60 Hz | 100~240V AC Input | ||
| 12V3A DC Output | / | Same | |||
| Dimension | 190 x 70 x 45 mm | 14369.543mm | |||
| (HWD) | 1248348.5mm | / | Different | ||
| Weight | Approx. 225 g | 650g | 186g | / | Different |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | |||||
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy | |||||
| medium | Xenon Arc lamp | Xenon Arc Flashlamp | Xenon Quartz Tube | Xenon Arc | |
| Flashlamp | Same | ||||
| Wavelength | |||||
| range | 470nm-1200nm | 475nm-1200nm | 470nm~1100nm | 475-1100nm | Similar |
| Comparison | |||||
| Elements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Remark |
| Energy | |||||
| density | Max 5.0 J/cm² | Max 5.0 [J/cm²] | 1.3~2.49J/cm² | 4-6J/cm² | Similar |
| Spot size | 3.0cm² ± 0.5cm² | 1.72 cm² or 3.02 cm² | 3cm² | 3.8cm² | Same |
| Pulse | |||||
| duration | 4-10ms | 11-12 ms | 11.5-15ms | 2-10ms | Similar |
| Pulsing | |||||
| control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery | |||||
| device | Direct illumination | ||||
| to tissue | Direct illumination | ||||
| to tissue | Direct illumination to | ||||
| tissue | Direct illumination | ||||
| to tissue | Same | ||||
| Output | |||||
| intensity level | 5 Levels | 5 Levels | 5 Levels | 6 Levels | Same |
| Software/ | |||||
| Firmware/ | |||||
| Microprocess | |||||
| or Control? | Yes | Yes | Yes | Yes | Same |
| Additional features | |||||
| Electrical | |||||
| safety | ANSI | ||||
| AAMI | |||||
| ES60601-1 | |||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| IEC 60601-2-83 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-2-57 | IEC 60601-1 | ||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| IEC 60601-2-83 | ANSI/AAMI | ||||
| ES60601-1 | |||||
| IEC 60601-1-2 | |||||
| IEC 60601-1-11 | |||||
| IEC 60601-2-57 | Same | ||||
| Eye safety | IEC 62471 | / | IEC 62471 | IEC 62471 | Same |
| Biocompatibi | |||||
| lity | ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-5 | ||||
| ISO 10993-10 | ISO 10993-5 | ||||
| ISO 10993-10 | Same |
5
6
Non-clinical studies and performance data VIII.
Non-clinical tests were 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 and reference devices. The test results demonstrated that the subject device complies with the following standards:
1) Biocompatibility Testing
The device has been tested for biocompatibility, it complies with the following standards:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
7
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
3) Eye Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
5) Usability
The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.
IX. Conclusions
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 and reference devices.