(62 days)
Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.
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.
The provided FDA 510(k) Summary for the "Intense pulsed light therapy apparatus" describes the device's technical characteristics and how it compares to predicate devices to establish substantial equivalence. However, it does not present acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its efficacy (e.g., hair removal effectiveness) in the format of a clinical study with a test set, ground truth, expert adjudication, or MRMC studies.
The "Performance Data" section primarily focuses on non-clinical performance data (biocompatibility, electrical safety, EMC, eye safety, software V&V, and usability testing), which are crucial for safety but do not assess the primary clinical function (hair removal efficacy).
Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and a study proving clinical efficacy, as that type of study is not detailed in this document.
However, I can extract and state what is provided regarding the safety and non-clinical performance, and explicitly mention what is missing per your request.
Based on the provided K241120 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and adherence to safety standards, rather than proving performance against specific quantitative clinical acceptance criteria for hair removal efficacy.
| Area of Performance | Acceptance Criteria (Implicit from Standards/Comparison) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets ISO 10993-5, ISO 10993-10, ISO 10993-23 for in vitro cytotoxicity, skin sensitization, and irritation. | Passed all specified ISO 10993 tests. |
| Electrical Safety & EMC | Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-11, IEC 60601-2-83 standards. | Passed all specified IEC 60601 electrical safety and EMC tests. |
| Eye Safety | Meets IEC 62471 standard for photobiological safety. | Met IEC 62471. |
| Software Verification & Validation | All software requirement specifications are met and all software hazards mitigated to acceptable risk levels (consistent with moderate level of concern). | System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated. |
| Usability | Evaluated according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Evaluation performed as per FDA guidance. |
| Technological Characteristics (for Substantial Equivalence) | Similar intended use, wavelength range, energy density, spot size, pulse duration, and safety features to predicate devices. | Wavelength range (510-1200nm), energy density (1.2-3.5 J/cm²), spot size (3.0 cm²), and pulse duration (3.5-4.5ms) were found to be "similar" to predicate and reference devices, with "minor differences" not raising safety/efficacy issues. |
2. Sample size used for the test set and the data provenance:
- Clinical Efficacy Test Set: Not mentioned or detailed. The document primarily focuses on non-clinical/safety testing and comparison to predicates.
- Safety Testing (e.g., Biocompatibility, Electrical Safety): These involve laboratory sample sizes specific to the tests (e.g., cell cultures, test circuits), not human subjects for efficacy. Data provenance is implied to be from laboratory testing conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study with human subjects requiring ground truth establishment is not described in the provided text.
- For Safety/Technical Data: The "experts" would be the engineers, toxicologists, and quality control personnel performing the specified lab tests and evaluations. Their qualifications are implicit in their ability to perform and interpret these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study is not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an IPL hair removal apparatus, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to its stated function or the type of data presented in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device for treatment, not a standalone algorithm.
7. The type of ground truth used:
- For Clinical Efficacy: Not applicable, as a clinical efficacy study is not described.
- For Safety/Non-Clinical Data: Ground truth is established by regulatory standards and established laboratory test methods (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). Passing these tests constitutes meeting the safety "ground truth."
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its software components are primarily for device control, safety interlocks, and user interface, verified via standard software V&V methods rather than machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is mentioned.
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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)
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 GoldenhotMedical TechnologyCo., Ltd. | 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 | Jul. 31, 2023 |
| Shenzhen FansizheScience AndTechnology Co., Ltd | Intense Pulsed Light (IPL) System,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, modelOBT-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 |
|---|---|---|---|
| Intensepulsedlighttherapyapparatus(lightoutlet, enclosure) | ABS+PC+POM | Surface-contactingdevice: 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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| ComparisonElements | Subject Device | Primary PredicateDevice | Secondary predicatedevice | Reference device | Remark | |
|---|---|---|---|---|---|---|
| 510(k) Number | K241120 | K231613 | K221569 | K213041 | / | |
| Trade name | Intense pulsed light therapyapparatus | Intense pulsed light device | Intense Pulsed Light (IPL)System | IPL Hair RemovalDevice | / | |
| Model | FDA01, FDA02, FDA03,FDA06, FDA07, FDA08FDA04S, FDA05S, FDA06S,FDA07S, FDA09S, FDA10S | DE01A-B, DE01A-G,DE01B-B, DE01BG,DE01C-B, DE01C-G,DE02A-B, DE02A-G,DE02B-B, DE02B-G,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 | |
| Deviceclassification | Class II | Class II | Class II | Class II | Same | |
| Indication for use/Intended use | Intense pulsed light therapyapparatus is an over-the-counter device intended forremoval of unwanted bodyand/or facial hair. | The Intense pulsed lightdevice is an over-the-counter device, intendedfor removal of unwantedbody and/or facial hair. | The Intense Pulsed Light(IPL) System is an over-the-counter device intended forthe removal of unwantedbody hair. | The IPL Hair RemovalDevice OBT-02 Versionis indicated for theremoval of unwantedhair. The device is alsoindicated for thepermanent reduction inhair regrowth, defined asthe long-term, stablereduction in the numberof hairs re-growing whenmeasured at 6, 9 and 12months after thecompletion of a | Same | |
| ComparisonElements | Subject Device | Primary PredicateDevice | Secondary predicatedevice | Reference device | Remark | |
| treatment regime.Thedevice is used for adults. | ||||||
| PrescriptionorOTC | OTC | OTC | OTC | OTC | Same | |
| EnvironmentofUse | 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 externaladapter | Same | |
| Power supply | Input: 100-240V~, 50/60Hz | Input: AC 100 ~ 240V,50/60 Hz, 1.0A | Input:100-240V50/60Hz, 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,FDA04S, FDA06, FDA06S,FDA07, FDA07S, FDA08,FDA10S: 1.2 | 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 | 4~12ms for T015C | 3ms | Similar | |
| ComparisonElements | Subject Device | Primary PredicateDevice | Secondary predicatedevice | Reference device | Remark | |
| Pulsing control | Finger switch | $(±2.0)ms$Finger switch | Finger switch | Finger switch | Same | |
| Outputintensitylevel | 5 levels | 5 levels | Unknown | 5 Levels | Same | |
| Delivery device | Direct illumination to tissue | Direct Illumination toTissue | Direct Illumination toTissue | Direct illuminationto tissue | Same | |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes | Same | |
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | Same | |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Unknown | Same | |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 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.
§ 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.