(56 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on standard IPL technology and hardware variations.
No
The device is intended for removal of unwanted body and/or facial hair, which is a cosmetic purpose and not for treating or diagnosing a disease or condition.
No
The device's intended use is "removal of unwanted body and/or facial hair," which is a treatment or cosmetic purpose, not diagnosis. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it includes a "main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window)" which are physical hardware components. The software verification and validation mentioned is for controlling this hardware.
No, 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 aesthetic purpose, not a diagnostic one.
- Device Description: The device uses IPL (Intense Pulsed Light) technology to target hair follicles. This is a physical treatment method, not a method for examining specimens from the human body.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a person's health condition.
- Over-the-Counter Device: IVDs are typically used in clinical settings or require specific training for interpretation, not generally sold over-the-counter for personal use in this manner.
IVD devices are used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This IPL device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
OHT
Device Description
The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG sixteen models. All have adopted the same structure design, consisting of IPL Hair Removal Device main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly appearance, cooling function and enclosure color, letter A in the model name means with skin cooling function, letter B means without skin cooling function, letter L means the enclosure color is light green, letter G is deep green, which do not affect the intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair.
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)
- Biocompatibility Testing:
The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted 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 September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5:2009. Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
- Electrical Safety and EMC:
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
- 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. -
Usability:
The product usability has been evaluated and verified according to the following FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016. -
Performance Testing:
Product output energy density has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
Product pulse duration has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
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.
Not Found
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
April 25, 2023
Shenzhen Xiazhifeng Electronic Co., Ltd. % Tracy Che Registration engineer Feiving Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China
Re: K230549
Trade/Device Name: IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG 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 28, 2023 Received: February 28, 2023
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
1
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 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) K230549
Device Name
IPL Hair Removal Device
Model(s): FY-B505AG, FY-B505AG, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG
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 Xiazhifeng Electronic Co., Ltd.
201, No. 39, Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen, Guangdong, China Post code: 518116 Tel.: +86 0755-28992929 James Li General Manager Tel: +86 13760395988 Email: 2850977367@qq.com Date of preparation: 2023-4-6
II. Device
Name of Device: IPL Hair Removal Device Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG 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 Devices
Primary predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Junbobeauty | |||
| Technology Co., Ltd | IPL HAIR REMOVAL | ||
| HANDSET (IPL-666) | K220669 | May 16, 2022 |
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Mareal Tech Co., Ltd | Home use hair removal device (T4, T5, T8, T4-01, T5-01, T8-01, T7) | K220248 | July 1, 2022 |
4
IV. Device Description
The IPL Hair Removal Device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AG, FY-B509AG, FY-B509BL, FY-B509BG sixteen models. All have adopted the same structure design, consisting of IPL Hair Removal Device main unit and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly appearance, cooling function and enclosure color, letter A in the model name means with skin cooling function, letter B means without skin cooling function, letter L means the enclosure color is light green, letter G is deep green, which do not affect the intended use.
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. Comparison of Technological Characteristics With the Predicate Device
The 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 devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
| Comparison
Elements | Subject Device | Primary Predicate
Device | Predicate Device | Remark |
|------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------|--------|
| 510(k)
Number | Pending | K220669 | K220248 | / |
| Trade name | IPL Hair Removal
Device
(FY-B505AL, FY-B505AG,
B505BL,
B505BG,
B507AL,
B507AG) | IPL
HAIR
REMOVAL
HANDSET
(IPL-666) | Home use hair removal
device
(T4, T5, T8, T4-01, T5-
01, T8-01, T7) | / |
5
| | B507BL,
FY-
B507BG,
FY-
B508AL,
FY-
B508AG,
FY-
B508BL,
FY-
B508BG,
FY-
B509AL,
FY-
B509AG,
FY-
B509BL,
FY-
B509BG) | | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | Shenzhen Xiazhifeng
Electronic Co., Ltd. | Shenzhen Junbobeauty
Technology Co., Ltd | Shenzhen Mareal Tech
Co., Ltd | / |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Device
classification | 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. | IPL HAIR
REMOVAL
HANDSET is an
over-the-counter
device intended for
removal of unwanted
body and/or facial
hair. | The Home use hair
removal device is an
over-the-counter device
intended for removal of
unwanted 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, in
patients with
Fitzpatrick Skin
Phototypes I-V. | Same |
| Prescription
or OTC | OTC | OTC | OTC | Same |
| Applicable
skin | Fitzpatrick Skin
Types I-V | Fitzpatrick Skin
Phototypes I-V | Fitzpatrick skin types I
- V | Same |
| Treatment
area | Small areas such as
underarm, bikini
line.
Large areas such as
legs, arms. | Used on facial hair
below the chin line,
arms, legs,
underarms, bikini
line. | Small areas such as
underarm and facial
hair below the chin
line.
Large areas such as
legs. | Similar |
| Device design | | | | |
| Source energy | Supplied by
external adapter | Supplied by external
adapter | Supplied by external
adapter | Same |
| Power supply | 100-240V
AC
Input
12V3A DC Output | 100240V AC Input4.3 J/cm² | Similar |
12V3A DC Output | Unknown | Same |
| Dimension | 3661.5183 mm | 1248348.5mm | Unknown | Different |
| 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 Flashlamp | Xenon Quartz Tube | Xenon Arc Flashlamp | Similar |
| Wavelength
range | 510-1100nm | 470-1100nm | 530-1100nm | Similar |
| Energy
density | 1.1 ~ 3.0 J/cm² | 1.3-2.49 J/cm² | 2.0
| Output energy | 4.0 J10.8 J | Level 1: 3.92J9.6 ms | Similar |
Level 2: 4.72J
Level 3: 5.62J
Level 4: 6.49J
Level 5: 7.48J | 7.8-15.39 J | Similar |
| Spot size | 3.6 cm² | 3 cm² | 3.5 cm², 3.9 cm² | Similar |
| Pulse duration | 5.0±2.0 ms | 11.5-15 ms | 5.0
| Pulsing
control | Finger switch | Finger switch | Finger switch | Same |
| Delivery
device | Direct illumination
to tissue | Direct
illumination
to tissue | Direct illumination
to
tissue | Same |
| Output
intensity level | 5 Levels | 5 levels | 5 levels | Same |
| Software/
Firmware/
Microprocess
or Control? | Yes | Yes | Yes | Same |
| Additional features | | | | |
| Electrical
safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-57
IEC 60601-2-83 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibil
ity | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
6
7
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted 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 September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009. Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
-
ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
2) Electrical Safety and EMC
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 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.
5) Usability
The product usability has been evaluated and verified according to the following FDA guidance
8
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
6) Performance Testing
Product output energy density has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
Product pulse duration has been tested and verified according to product specification and the test results have confirmed that this parameter complied with specification requirement.
VIII. 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 devices.