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The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.

The IPL Hair Removal is a personal. light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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 finger switch. The device mainly contains a Xenon lamp and a skin sensor 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. The device is for single-person use only. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) 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. In addition, the device is equipped with a manual shaver and sunglass. The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode). For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) 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. In addition, the device is equipped with a manual shaver, sunglass and replacement lampshade. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.

The provided text is a 510(k) summary for an IPL Hair Removal device. It mostly focuses on comparing the subject device to predicate devices for substantial equivalence and outlining non-clinical tests conducted. Unfortunately, it explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot provide information on acceptance criteria based on clinical studies, device performance from such studies, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or training set details as this information is not present in the given document.

The document only details non-clinical tests for electrical safety, electromagnetic compatibility, biocompatibility, and software verification/validation.

Here's the information that can be extracted based on the provided text regarding non-clinical tests:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not applicable for clinical studies. The document mentions non-clinical tests, for which "test sets" in the context of clinical data/patients are not relevant. Details about the specific samples (e.g., number of units tested) for electrical, EMC, and biocompatibility tests are not provided.
• Data Provenance: Not applicable as no clinical data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical data or expert evaluations for ground truth establishment are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical data or adjudication for a test set is mentioned.

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. The device is an IPL Hair Removal device, not an AI-assisted diagnostic or interpretative tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. The device is a physical IPL hair removal device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" is typically defined by the standards themselves, and compliance is assessed against the requirements of those standards.

8. The sample size for the training set:

• Not applicable. No clinical data or machine learning model requiring a training set is mentioned for the device. The software mentioned is for device control, not for data analysis or interpretation with AI.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI/ML model is mentioned.

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The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.

The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using IPL technology. The device provides hair reduction using Intense Pulsed Light (IPL) technology. 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 finger switch. The device mainly contains a Xenon lamp and a skin sensor 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. The device is for single-person use only.

The IPL Hair Removal includes SL-B080, SL-B126, and SL-B136 three models. The difference of all models is mainly the exception of appearance and number of buttons which do not affect the intended use. For model SL-B080, it consists of an IPL beauty device main body 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. In addition, the device is equipped with a manual shaver, sunglasses and replacement lampshade in addition to the IPL beauty device main body and adapter. The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.

For model SL-B126 and SL-B136, consisting of IPL beauty device main body 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. In addition, the device is equipped with a manual shaver and sunglasses in addition to the IPL beauty device main body and adapter.

The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device), Auto/Manual button and Flash button.

The provided text describes a 510(k) premarket notification for an IPL Hair Removal device (models SL-B080, SL-B126, SL-B136). The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing new acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical performance studies, is largely not present in this regulatory document.

However, based on the provided text, I can extract and infer some information related to safety and performance testing that serves as a form of acceptance criteria for regulatory clearance.

1. Table of Acceptance Criteria (Based on Compliance with Standards) and Reported Device Performance

• ISO 10993-5:2009/(R)2014 (Tests for In Vitro Cytotoxicity)
• ISO 10993-10:2010/(R)2014 (Tests for Irritation and Skin Sensitization) |
  | Electrical Safety: Device must meet general and collateral safety standards for medical electrical equipment. | Complied with:
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-1 (Basic safety and essential performance)
• IEC 60601-1-11 (Medical Electrical Systems Used in the Home Healthcare Environment)
• IEC 60601-2-57 (Non-laser source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) |
  | Eye Safety: Device must meet photobiological safety standards. | Complied with:
• IEC 62471 (Photobiological safety of lamps and lamp systems)
• IEC 60601-2-57 (re-emphasized for non-laser source equipment) |
  | Usability: Device must meet standards for usability in medical electrical equipment. | Complied with:
• IEC 60601-1-6 (Usability) |
  | Software Verification and Validation: Software must meet specified requirements and mitigate hazards. | Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated all software requirement specifications are met and hazards mitigated. |
  | Performance Equivalence: Device performance characteristics (wavelength, pulse duration, energy density, spot size) should be comparable to predicate devices. | Wavelength Range: 510-1100nm (Same as Predicate 1, Predicate 2 not publicly available)
  Pulse duration: 9-12 milliseconds (Similar to Predicates 1 & 2)
  Energy density: 2.2-4.0J/cm² (Similar to Predicates 1 & 2, noted as not raising new safety/effectiveness issues)
  Spot size: 3.0cm² (Same/similar to Predicates 1 & 2) |

2. Sample size used for the test set and the data provenance

The document does not detail specific human subject test sets or their sample sizes for proving the device's efficacy in hair removal. The "Test Summary" primarily refers to lab bench testing for biocompatibility, electrical safety, eye safety, and software verification/validation, which do not typically involve human subjects or data provenance in the clinical sense. These tests are performed in a laboratory setting on the device itself or on materials representative of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are laboratory-based compliance tests against international standards, not clinical studies requiring expert-established ground truth for specific clinical outcomes.

4. Adjudication method for the test set

Not applicable. The tests described are laboratory-based compliance tests, not clinical studies that would typically involve adjudication of results by multiple human readers.

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 device, not an AI-powered diagnostic tool, and the submission does not involve an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm, and the submission does not describe standalone algorithm performance.

7. The type of ground truth used

The "ground truth" in this context is the international and recognized consensus standards (e.g., ISO, IEC) for safety and performance. The device is deemed safe and effective if it successfully passes these predefined tests.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set. The tests performed are for device safety and performance, not for training a model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device and submission.

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