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510(k) Data Aggregation
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.
The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.
The provided text is a 510(k) Premarket Notification summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data from non-clinical testing. It does not present any clinical study data or acceptance criteria related to device efficacy for hair removal based on human trials.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to a clinical outcome (e.g., hair reduction percentage).
- Sample size and data provenance for a test set for clinical performance.
- Number of experts and their qualifications for establishing clinical ground truth.
- Adjudication method for a clinical test set.
- MRMC comparative effectiveness study results.
- Algorithm-only (standalone) performance.
- Type of ground truth used for clinical efficacy.
- Sample size and ground truth establishment for a training set.
The document primarily covers non-clinical performance data, which includes:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical):
The acceptance criteria for this device are implied by its conformance to various international standards for safety and biocompatibility, as well as the demonstration of similar technological characteristics to predicate devices. The "reported device performance" is framed as successfully meeting these standards and being comparable to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must not cause adverse biological reactions when in contact with the body. Conformance to ISO 10993-5, ISO 10993-10, and ISO 10993-23. | Passed: Testing conducted per ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Skin sensitization), and ISO 10993-23 (Skin irritation). (Section VIII.1) |
| Electrical Safety & EMC | Device must be electrically safe and comply with electromagnetic compatibility standards for medical electrical equipment, including home healthcare use. Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83. | Passed: Testing performed to and passed the following standards: ANSI AAMI ES60601-1 (Medical electrical equipment for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-1-11 (Home Healthcare Environment), and IEC 60601-2-83 (Basic safety and essential performance of home light therapy equipment). (Section VIII.2) |
| Eye Safety | Device emissions must meet photobiological safety standards. Conformance to IEC 62471. | Passed: Testing performed to IEC 62471 (Photobiological safety of lamps and lamp systems). (Section VIII.3) |
| Software V&V | Software must be verified and validated to meet requirements and mitigate hazards, consistent with a moderate level of concern. | Demonstrated: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and all software hazards mitigated to acceptable risk levels. (Section VIII.4) |
| Technological Equivalence | Key technical specifications (wavelength, energy density, spot size, pulse duration, light source, etc.) must be similar to legally marketed predicate devices, with any differences not raising new safety or effectiveness concerns. | The device's wavelength range (LS-T106: 610-1200nm, LS-T107: 560-1200nm, LS-T108: 470-1200nm) is considered similar to predicates (e.g., predicate device 550-1200nm, reference device 1 470-1200nm). Differences like the min wavelength of LS-T106 being identical to reference device 4's range are noted. (Note 2, Section VII) |
| Energy density (LS-T106: 2.0-4.87J/cm², LS-T107: 2.16-5.18J/cm², LS-T108: 2.0-5.62J/cm²) and output energy are considered similar, accounting for a ±20% error, and falling within the range of predicate and reference devices. (Note 3, Section VII) | ||
| Spot sizes (LS-T106: 3.2 cm², LS-T107: 3.7 cm², LS-T108: 3.2 cm²) are similar to reference devices (3.0-3.6cm²). (Note 4, Section VII) | ||
| Pulse durations (LS-T106: 0.64-2.4ms, LS-T107: 7.2-10.8ms, LS-T108: 6.8-10.2ms) are within or overlap with the ranges of predicate and reference devices. (Note 5, Section VII) | ||
| The differing number of output intensity levels (3 for subject vs. 5-9 for others) is deemed not to raise safety or effectiveness issues due to comparable wavelength, energy, and density, and compliance with relevant standards. (Note 6, Section VII) |
Regarding your specific questions related to clinical efficacy studies (which are NOT in this document):
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth for efficacy is provided.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set or adjudication process is mentioned.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document does not describe such a study.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-only device, but a physical hair removal device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical efficacy study reported. For the non-clinical tests, the "ground truth" is defined by the specific requirements and passing criteria of the referenced international standards.
- 8. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set of patient data.
- 9. How the ground truth for the training set was established: Not applicable.
In summary: The provided FDA 510(k) summary for the IPL Hair Removal Device focuses on demonstrating substantial equivalence through non-clinical performance data (biocompatibility, electrical safety, eye safety, software validation) and comparison of technological characteristics with legally marketed predicate devices. It does not include any data or studies related to its clinical efficacy in hair removal (e.g., percentage of hair reduction) on human subjects. For medical devices like this, approval based on substantial equivalence often relies on demonstrating that the new device has similar technology and performance/safety characteristics to products already on the market, rather than requiring new clinical efficacy trials if the intended use and technological principles are well-established.
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(88 days)
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth 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 device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.
Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.
Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.
The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results for the new device's performance.
Therefore, the document explicitly states: "There was no clinical testing performed."
As such, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not available in the provided text.
The document primarily discusses non-clinical tests performed to ensure safety and effectiveness by complying with recognized consensus standards (e.g., electrical safety, EMC, biocompatibility, software verification). The "Discussion of Non-Clinical Tests Performed for Safety and effectiveness" section lists these standards but does not provide specific performance metrics or acceptance criteria related to a clinical outcome of hair removal effectiveness for the subject device.
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