(78 days)
Not Found
No
The device description focuses on basic hardware components (Xenon lamp, skin sensor, cooling function) and safety features. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typically associated with AI/ML-powered devices.
No
Therapeutic devices are generally defined as those intended to treat or alleviate a disease, injury, or medical condition. This device is indicated for hair removal and permanent reduction in hair regrowth, which is considered a cosmetic rather than a medical therapy.
No
The device is described as an "IPL Hair Removal Device" intended for "removal of unwanted hair" and "permanent reduction in hair regrowth." It uses IPL technology to reduce hair growth. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly outlines hardware components such as a Xenon lamp, built-in skin sensor, external power adapter, and a finger switch for activation. It also mentions a cooling function. While software is mentioned for verification and validation, the core functionality and components are hardware-based.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "IPL Hair Removal Device" that uses light to reduce hair growth. It works below the skin's surface and does not involve analyzing any biological samples taken from the body.
- Intended Use: The intended use is for "removal of unwanted hair" and "permanent reduction in hair regrowth." This is a cosmetic or aesthetic application, not a diagnostic one.
The information provided focuses on the device's physical operation, safety standards (biocompatibility, electrical, eye), and software validation, all of which are typical for a non-IVD medical device or consumer product with a medical claim.
N/A
Intended Use / Indications for Use
IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Product codes
OHT
Device Description
The subject device 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personal, light-based, hair reduction device intended to be sold over-the-counter 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)
- Biocompatibility Safety: The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-23 Biological Evaluation of Medical Devices -- Part23:Tests for irritation
- Electrical Safety and EMC Safety: Electrical safety and Eye safety testing was performed to, and passed, 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
- IEC 60601-1 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 documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.
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 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.
December 15, 2023
Shenzhen Borria Technology Co., Ltd % Bing Huang Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Oianhai Road, Nanshan District Shenzhen, Guangdong 518000 China
Re: K232939
Trade/Device Name: IPL Hair Removal Device 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: September 20, 2023 Received: September 20, 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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Hithe -Tanisha L. s 2023.12.15 Hithe -S 17:48:23 -05'00'
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K232939
Device Name
IPL Hair Removal Device, Model(s): BR223, BR225
Indications for Use (Describe)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
| 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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4
510(k) Summary
''510(k) Summary'' as required by 21 CFR Part 807.92.
Date: 2023-12-8
I. Submitter
SHENZHEN BORRIA TECHNOLOGY CO., LTD. Shenyan Road No.2015 Room 501 Building No.6 Pengwan Community, Haishan Sub-district Yantian District, Shenzhen. Post code: 518081 Tel.: +86 755 8316 7375
Tiantian Wang Project Leader Tel.: +86 133 1290 5505 Email: 466144494@qq.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): BR223, BR225 Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification 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
| Manufacturer | Predicate Device | 510(k)
Number | Approval Date |
|----------------|-----------------------------------------------|------------------|---------------|
| CyDen Limited. | iPulse SmoothSkin Gold Hair
Removal System | K160968 | Apr. 14, 2016 |
Predicate device:
| Manufacturer | Predicate Device | 510(k)
Number | Approval Date |
|-----------------------------------------|-------------------------|------------------|----------------|
| Shenzhen Yangyi
Technology Co., Ltd. | IPL Hair Removal Device | K230021 | March 31, 2023 |
IV. Device Description
5
The subject device 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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.
V. Indications for Use
The IPL Hair Removal Device is indicated for the removal for unwanted hair. The IPL Hair Removal Device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of the treatment regime.
VI. Comparison of Technological Characteristics With the Predicate Device
The subject device IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the subject device may be found substantially equivalent to its predicate device.
The subject device is compared with the following Predicate Device in terms of intended use, design, specifications, and performance:
| Comparison
Elements | Subject Device | Primary Predicate device
K160968 | Predicate device
K230021 |
|------------------------|----------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------|
| K Number | Pending | K160968 | K230021 |
| Trade name | IPL Hair Removal Device,
Model(s): BR223, BR225 | iPulse SmoothSkin Gold
Hair Removal System | IPL Hair Removal Device,
Model(s): AP10, AP20,
AP30, AP32 |
| Wavelength range | 5101100nm | 5101100nm | 5301100nm |6J/cm² | Max.4.3J/ cm² |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Energy density | Max.6.0J/cm² | 3
| Spot size | 3.36cm² | 3cm²(3cm by 1cm) | 3.3cm², 3.96 cm², 3.63 cm² |
| Pulse duration | 812ms | 2ms to10ms | 8.813.2ms |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue |
6
SHENZHEN BORRIA TECHNOLOGY CO., LTD. 510(k)s -Section 8. 510(k) Summary
| Comparison
Elements | Subject Device | Primary Predicate device
K160968 | Predicate device
K230021 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use/Intended use | The IPL Hair Removal
Device is indicated for the
removal for unwanted hair.
The IPL Hair Removal
Device is also indicated for
the permanent reduction in
hair regrowth, defined as
the long-term, stable
reduction in the number of
hairs regrowing when
measured at 6, 9 and 12
months after the
completion of the treatment
regime. | The iPulse SmoothSkin
Gold Hair Removal System
is indicated for the removal
of unwanted hair. The
iPulse SmoothSkin Gold is
also indicated for the
permanent reduction in hair
regrowth, defined as the
long-term, stable reduction
in the number of hairs
regrowing when measured
at 6,9 and 12 months after
the completion of a
treatment regime. | The IPL Hair Removal
Device is an over-the-
counter device intended for
removal of unwanted body
and/or facial hair. |
| Location for use | OTC | OTC | OTC |
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
-
ISO 10993-23 Biological Evaluation of Medical Devices -- Part23:Tests for irritation
2) Electrical Safety and EMC Safety
Electrical safety and Eye safety testing was performed to, and passed, 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
-
IEC 60601-1 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
7
3) Eye Safety
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Summary
Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions VIII.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials, and performance, the subject device IPL Hair Removal Device is considered to be substantially equivalent to the predicate device.