(87 days)
No
The document does not mention AI or ML, and the device description focuses on basic safety features like a skin sensor and finger switch activation, which are not indicative of AI/ML technology.
Yes
The device is intended for "removal of unwanted body and/ or facial hair" and works by "reducing hair growth with minimal pain," which is a physiological effect on the body for a non-cosmetic purpose, thus categorizing it as a therapeutic device.
No
The device is described as an "IPL Hair Removal Device" intended for "removal of unwanted body and/ or facial hair," which is a treatment, not a diagnostic function.
No
The device description explicitly details physical hardware components such as an external power adapter, finger switch, skin sensor, and flash window, indicating it is a hardware device that utilizes software for control and safety features.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "removal of unwanted body and/ or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The description focuses on the mechanism of action (IPL for hair reduction) and safety features (skin sensor, power adapter). It does not mention any analysis of biological samples.
- Lack of Diagnostic Information: There is no indication that this device provides any information about a person's health status, disease, or condition based on the analysis of biological specimens.
Therefore, this device falls under the category of a therapeutic or aesthetic device, not 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 (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Hair Removal Device (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, homeuse and personal device for hair reduction based on 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 indications for use, performance, structure design and operation of these five models of the device are basically the same, there is only a minor difference in appearance and physical dimension. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product is equipped with a skin sensor to detect appropriate skin contact, if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
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. Suitable but not limit to upper lip, bikini line, armpit, legs, arms
Indicated Patient Age Range
The secondary predicate device K213041 states "The device is used for 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)
- 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 -Par t 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 irritation
- Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic 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 according to the following FDA guidance: > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Summary: Based on the above performance as documented in this application, IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate 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 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
Dongguan Lide Electric Appliance 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: K232056
Trade/Device Name: IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 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: July 11, 2023 Received: July 11, 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 (the 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/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.
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"
1
(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 OS 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-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.
| Tanisha L. |
|---|
| Hithe -S |
| Tanisha L. Hithe -S |
|---|
| 2023.10.06 |
| 16:07:32 -04'00' |
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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232056
Device Name IPL Hair Removal Device Model(s): PB1, PB2, PB3, PB4, TM002
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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4
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Dongguan Lide Electric Appliance Co., Ltd Floor 4, Building 2, No.11 Yinhe Fifth Road, Qiaotou Town, Dongguan City, Guangdong, China Post code: 523528 Fax: +86-0769-81282267
Xiang Guojun Deputy general manager Tel.: +86 18998439876 Email: SZ XGJ@126.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): PB1, PB2, PB3, PB4, TM002 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 |
|---|---|---|---|
| Shenzhen | |||
| Technology Co. Ltd. | Bosidin IPL Home Use Hair Removal | ||
| Device | K192432 | Nov. 08, 2019 |
Secondary predicate device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Glan Electronics Co., Ltd. | IPL Hair Removal, Model: | ||
| OBT-02 | K213041 | Nov. 18, 2021 |
IV. Device Description
IPL Hair Removal Device (Model: PB1, PB2, PB3, PB4, TM002), is an over-the-counter, homeuse and personal device for hair reduction based on 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.
5
The indications for use, performance, structure design and operation of these five models of the device are basically the same, there is only a minor difference in appearance and physical dimension. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product is equipped with a skin sensor to detect appropriate skin contact, if the flash window of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
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 (Enclosure | |||
| and flash window) | ABS, PC | 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".
VII.Comparison of Technological Characteristics With the Predicate Device
IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. 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, specifications and performance:
| Comparison
| Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
|---|---|---|---|---|
| 510(k) | ||||
| Number | Pending | K192432 | K213041 | / |
| Trade name | IPL Hair Removal | |||
| Device | IPL Home Use Hair | |||
| Removal Device (model: | ||||
| D-1130) | IPL Hair Removal, Model: | |||
| OBT-02 | / | |||
| Manufacturer | Dongguan Lide | |||
| Electric Appliance Co., | ||||
| Ltd | Shenzhen Bosidin | |||
| Technology Co. Ltd. | Glan Electronics Co., Ltd. | / | ||
| Regulation | ||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Comparison | ||||
| Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| 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 Home Use Hair | |||
| Removal Device is an over- | ||||
| the-counter device intended | ||||
| for removal of unwanted | ||||
| body and/or facial | ||||
| hair. | The IPL Hair Removal Device | |||
| OBT-02 Version is indicated | ||||
| for the removal of unwanted | ||||
| hair. The device is also | ||||
| indicated for the permanent | ||||
| reduction in hair regrowth, | ||||
| 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 regime. The device | ||||
| is used for adults. | Same | |||
| Prescription | ||||
| or OTC | OTC | OTC | OTC | Same |
| Device design | ||||
| Treatment | ||||
| area | Suitable but not limit | |||
| to upper lip, bikini | ||||
| line, armpit, legs, arms | Small areas such as the | |||
| underarm and face; Large | ||||
| areas such as the legs. | Unknown | Similar | ||
| Source | ||||
| energy | Supplied by external | |||
| adapter | An external power supply | Supplied by external adapter | Same | |
| Power supply | 100~240V, 50/60Hz | 100~240V, 50/60Hz | 100-240 V AC | Same |
| Dimension | ||||
| (mm) | PB1: 19412450 | |||
| PB2: 19214048 | ||||
| PB3: 19114048 | ||||
| PB4: 19114048 | ||||
| TM002: 19114048 | D-1130: 212x141x64mm | 150 x 75 x 45mm (HWD) | Different | |
| Weight | PB1: 280g | |||
| PB2: 283g | ||||
| PB3: 282g | ||||
| PB4: 281g | ||||
| TM002: 285g | D-1130: 340g | 220g | 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 arc lamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | ||||
| range | 510-1100nm | 510-1100nm | 510-1100nm | Same |
| Comparison | ||||
| Elements | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remark |
| Energy | ||||
| density | 1.5~3.5 J/cm² | 2.0~4.0J/cm² | 1.5~4.0J/cm² | Similar |
| Output | ||||
| energy | 6.5~15.5J | 9.5~18J | 4.5~12J | Similar |
| Spot size | 4.5cm² | 4.5cm² | 3.0 cm² | Same |
| Pulse | ||||
| duration | 3~14ms | 7.5~14ms | 3ms | Similar |
| 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 | 9 levels | 5 levels | 5 levels | Different |
| Software/ | ||||
| Firmware/ | ||||
| Microprocess | ||||
| or Control? | Yes | Yes | Yes | Same |
| Additional information | ||||
| 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 60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | Similar | |||
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibi | ||||
| lity | ISO 10993-5 | |||
| ISO 10993-10 | ||||
| ISO 10993-23 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | Same |
6
7
Performance Data VIII.
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:
8
-
ISO 10993-5:2009, Biological evaluation of medical devices -Par t 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 irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic 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 according to the following FDA guidance: > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Summary
Based on the above performance as documented in this application, IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate devices.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.