Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
Device Facts
| Record ID | K241120 |
|---|---|
| Device Name | Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) |
| Applicant | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. |
| Product Code | OHT · General, Plastic Surgery |
| Decision Date | Jun 24, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Device Story
Intense pulsed light (IPL) therapy apparatus for home-use hair reduction. Device uses xenon lamp to emit light pulses; operates below skin surface without cutting or pulling. Features skin sensor to ensure full contact before pulse emission; some models include cooling function. Powered by external adapter; operated by user via finger switch or auto-emission. Healthcare provider does not interact with device; user self-administers treatment. Output is light energy; intended to reduce hair growth. Benefits include non-invasive hair removal with minimal pain.
Clinical Evidence
Bench testing only. No clinical data provided. Performance supported by biocompatibility (ISO 10993-5, -10, -23), electrical safety/EMC (IEC 60601-1, -1-2, -1-11, -2-83), photobiological safety (IEC 62471), software validation, and usability engineering per FDA guidance.
Technological Characteristics
Hand-held IPL device; Xenon lamp energy source; 510-1200nm wavelength; 1.2-3.5 J/cm² energy density; 3.0cm² spot size; 3.5-4.5ms pulse duration. Materials: ABS, PC, POM. Powered by external AC adapter (100-240V). Includes skin contact sensor. Software-controlled. No sterilization required.
Indications for Use
Indicated for removal of unwanted body and/or facial hair in adults.
Regulatory Classification
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.
Predicate Devices
- Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01BG, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G (K231613)
- Intense Pulsed Light (IPL) System, model T013C, T015C, T015K (K221569)
Reference Devices
- IPL Hair Removal Device, model OBT-02 (K213041)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2024
Qiaocheng Li (Dongguan) Medical Instruments Co., LTD % Riley Chen RA Engineer Feiving Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K241120
Trade/Device Name: Intense pulsed light therapy apparatus (FDA01. FDA02. FDA04S. FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) 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: April 22, 2024 Received: April 23, 2024
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.
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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" (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 (OS) 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).
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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,
Digitally signed
Tanisha L. by Tanisha L.
Hithe -S
Hithe -S
Date: 2024.06.24
15:29:23 -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
Enclosure
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#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241120
Device Name
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
Indications for Use (Describe)
Intense pulsed light therapy apparatus 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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# 510(k) Summary
# K241120
# "510(k) Summary" as required by 21 CFR Part 807.92.
#### I. Submitter
Qiaocheng Li (Dongguan) Medical Instruments Co., LTD Room 302, Building 5, No.6, Lianhu Baoyuan Road, Tangxia Town, Dongguan City, Guangdong Province, China Post code: 523712
Huang Quanhua Title: Quality supervisor Tel.: +86-18681107912 Email: 1s4 5ogp59ash7@dingtalk.com Date: 2024.05.27
#### II. Device
Name of Device: Intense pulsed light therapy apparatus Model(s): FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S 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 & Reference Device
Predicate devices:
| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------|
| Zhuzhou Goldenhot<br>Medical Technology<br>Co., Ltd. | Intense pulsed light device,<br>Model(s): DE01A-B, DE01A-G,<br>DE01B-B, DE01BG, DE01C-B,<br>DE01C-G, DE02A-B, DE02A-G,<br>DE02B-B, DE02B-G, DE02C-B,<br>DE02C-G. | K231613 | Jul. 31, 2023 |
| Shenzhen Fansizhe<br>Science And<br>Technology Co., Ltd | Intense Pulsed Light (IPL) System,<br>model T013C, T015C, T015K | K221569 | Jun. 30, 2022 |
Reference device:
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| Manufacturer | Reference Device | 510(k) Number | Cleared Date |
|----------------------------|------------------------------------------|---------------|---------------|
| Glan Electronics Co., Ltd. | IPL Hair Removal Device, model<br>OBT-02 | K213041 | Nov. 18, 2021 |
# IV. Device Description
Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.
#### V. Indications for Use
Intense pulsed light therapy apparatus 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 |
|------------------------------------------------------------------------------------|-----------------------|-------------------------------------------|--------------------|
| Intense<br>pulsed<br>light<br>therapy<br>apparatus<br>(light<br>outlet, enclosure) | ABS+PC+POM | Surface-contacting<br>device: Intact skin | Less than 24 hours |
# VII.Comparison of Technological Characteristics With the Predicate Device
Intense pulsed light therapy apparatus has the same intended use as the predicate devices. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate devices and reference 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 and reference device for its intended use.
Intense pulsed light therapy apparatus is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:
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| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Secondary predicate<br>device | Reference device | Remark | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------|
| 510(k) Number | K241120 | K231613 | K221569 | K213041 | / | |
| Trade name | Intense pulsed light therapy<br>apparatus | Intense pulsed light device | Intense Pulsed Light (IPL)<br>System | IPL Hair Removal<br>Device | / | |
| Model | FDA01, FDA02, FDA03,<br>FDA06, FDA07, FDA08<br>FDA04S, FDA05S, FDA06S,<br>FDA07S, FDA09S, FDA10S | DE01A-B, DE01A-G,<br>DE01B-B, DE01BG,<br>DE01C-B, DE01C-G,<br>DE02A-B, DE02A-G,<br>DE02B-B, DE02B-G,<br>DE02C-B, DE02C-G. | T013C, T015C, T015K | OBT-02 | / | |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| Product code | OHT | OHT | OHT, ONF | OHT | Same | |
| Device<br>classification | Class II | Class II | Class II | Class II | Same | |
| Indication for use/<br>Intended use | Intense pulsed light therapy<br>apparatus is an over-the-<br>counter device intended for<br>removal of unwanted body<br>and/or facial hair. | The Intense pulsed light<br>device is an over-the-<br>counter device, intended<br>for removal of unwanted<br>body and/or facial hair. | The Intense Pulsed Light<br>(IPL) System is an over-the-<br>counter device intended for<br>the removal of unwanted<br>body hair. | The IPL Hair Removal<br>Device OBT-02 Version<br>is indicated for the<br>removal of unwanted<br>hair. The device is also<br>indicated for the<br>permanent reduction in<br>hair regrowth, defined as<br>the long-term, stable<br>reduction in the number<br>of hairs re-growing when<br>measured at 6, 9 and 12<br>months after the<br>completion of a | Same | |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Secondary predicate<br>device | Reference device | Remark | |
| | | | | treatment regime.<br>The<br>device is used for adults. | | |
| Prescription<br>or<br>OTC | OTC | OTC | OTC | OTC | Same | |
| Environment<br>of<br>Use | Home use | Home use | Home use | Home use | Same | |
| Design | Hand-hold | Hand-hold | Hand-hold | Unknown | Same | |
| Power source | An external power supply | An external power adapter | An external power adapter | Supplied by external<br>adapter | Same | |
| Power supply | Input: 100-240V~, 50/60Hz | Input: AC 100 ~ 240V,<br>50/60 Hz, 1.0A | Input:<br>100-240V<br>50/60Hz, 1.5A Max. | 100-240 V AC | Similar | |
| Sterilization | Not required | Not required | Unknown | Not required | Same | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same | |
| Energy medium | Xenon lamp | Xenon Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same | |
| Wavelength range | 510-1200nm (±15nm) | 510nm~1200nm | 510nm~1200nm | 510-1100nm | Same | |
| Energy density | FDA01, FDA02, FDA03,<br>FDA04S, FDA06, FDA06S,<br>FDA07, FDA07S, FDA08,<br>FDA10S: 1.2~2.64J/cm²<br>FDA05S, FDA09S:<br>1.3~3.5J/cm² | 1.2~4.1 J/cm² | 1.17~4.69J/cm² for T015C | 1.5-4.0J/cm² | Similar | |
| Spot size | 3.0cm² | 3.9 cm² | 3.5cm² for T015C | 3.0cm² | Similar | |
| Pulse duration | 3.5~4.5ms (±0.9ms) | Body mode: 7.0~9.0 (±2.0)ms<br>Face mode: 8.0~10.0 (±2.0)ms<br>Bikini mode: 9.0~11.0 | 4~12ms for T015C | 3ms | Similar | |
| Comparison<br>Elements | Subject Device | Primary Predicate<br>Device | Secondary predicate<br>device | Reference device | Remark | |
| Pulsing control | Finger switch | $(±2.0)ms$<br>Finger switch | Finger switch | Finger switch | Same | |
| Output<br>intensity<br>level | 5 levels | 5 levels | Unknown | 5 Levels | Same | |
| Delivery device | Direct illumination to tissue | Direct Illumination to<br>Tissue | Direct Illumination to<br>Tissue | Direct illumination<br>to tissue | Same | |
| Software/<br>Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | Yes | Same | |
| Electrical safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-57 | Same | |
| | Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Unknown | Same |
| | Biocompatibility | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Same |
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# VIII. 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 Intense Pulsed Light Therapy Apparatus 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
#### 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
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# Summary
Based on the above performance as documented in this application, the Intense Pulsed Light Therapy Apparatus 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.
