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Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.

The Intense Pulse Light Therapeutic Apparatus is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse.There are IPL-18 BF and IPL-18 FG two models in this application. Their work principle, intended use, structure, appearance, size, and composition are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

The FDA 510(k) summary for the Intense Pulse Light Therapeutic Apparatus (K242595) does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria for its intended use (removal of unwanted body hair).

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: The device shares the same intended use as its primary predicate: "removal of unwanted body hair."
• Operational Characteristics and Design: The summary compares various physical and technical characteristics (wavelength range, energy density, pulse duration, light source, etc.) to show similarities or non-significant differences with predicate devices.
• Compliance with Recognized Standards: The substantial equivalence is supported by showing compliance with a suite of international standards related to biocompatibility, electrical safety, electromagnetic compatibility (EMC), photobiological safety, and software verification/validation.

Here's an breakdown of the available information based on your request:

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

The document does not provide specific quantitative acceptance criteria for hair removal effectiveness (e.g., X% hair reduction after Y treatments) or reported performance data against such criteria. The reported performance is implicitly deemed acceptable by virtue of:

• Substantial Equivalence to Predicate Devices: The key "acceptance criterion" here is that the subject device's characteristics and safety/effectiveness profile are comparable enough to legally marketed predicate devices.
• Compliance with Safety Standards: Meeting standards for biocompatibility, electrical safety, EMC, and photobiological safety is presented as the primary performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical test set with human subjects to evaluate hair removal efficacy. The "test set" in this submission refers to the components and systems subjected to engineering (biocompatibility, electrical safety, EMC, etc.) and software validation testing. The data provenance for these engineering tests is generally from the manufacturer's testing or accredited labs, not specific countries or patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as there is no clinical test set for efficacy evaluation described in the submitted 510(k) summary. The "ground truth" for the engineering tests would be the specifications and requirements of the relevant IEC and ISO standards. The experts involved would be the engineers and quality personnel conducting the tests and verifying compliance. Their specific qualifications are not detailed in this summary.

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

This is not applicable as there is no clinical test set requiring adjudication in this 510(k) summary.

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

This is not applicable as the device is an Intense Pulse Light Therapeutic Apparatus for hair removal, which is not an AI-powered diagnostic device requiring human reader interpretation. No MRMC study was performed or is relevant.

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

This is not applicable as the device is a physical light therapy apparatus, not an algorithm. Performance is demonstrated through compliance with safety and engineering standards and comparison of physical and operational characteristics to predicate devices.

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

For the compliance testing:

• Biocompatibility, Electrical Safety, EMC, Eye Safety: The "ground truth" is compliance with the specified international standards (ISO 10993 series, IEC 60601 series, IEC 62471). This means the device met the predefined thresholds and requirements set out in these widely accepted safety and performance standards.
• Software Verification and Validation: The "ground truth" is that the software met its specified requirements and mitigated identified hazards, as demonstrated through validation testing against defined specifications.

There is no "ground truth" for hair removal efficacy (e.g., pre/post treatment hair counts, subject satisfaction scores, expert assessment of hair reduction) presented in this 510(k) summary.

8. The sample size for the training set

This is not applicable. The device is an Intense Pulse Light Therapeutic Apparatus. It is not an AI/ML algorithm that requires a training set. The "design" and "development" of the device would involve engineering prototypes and testing, but not in the context of a "training set" as it would apply to AI.

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

This question is not applicable as the device is not an AI/ML system requiring a training set with established ground truth.

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Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.

The Intense Pulse Light Therapeutic Apparatus is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are IPL-1 PRO, IPL-1, IPL-12, and IPL-17 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, size are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

The provided FDA 510(k) summary does not contain information on the acceptance criteria and study proving device performance as typically understood for AI/ML-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and standard safety and performance testing.

Here's a breakdown of why the requested information is absent and what is provided:

No AI/ML Performance Study Details:
The document does not describe an AI/ML component, nor does it detail a study proving specific performance metrics (like accuracy, sensitivity, specificity) against a clinical ground truth, which would typically involve acceptance criteria, test sets, expert adjudication, or MRMC studies.

The device, "Intense Pulse Light Therapeutic Apparatus," is a physical device for hair removal and does not appear to incorporate AI or machine learning. The section titled "Software Verification and Validation" primarily addresses the software aspect within the context of electrical safety and general device functionality, classifying it as "moderate level of concern" software, which is typical for embedded control systems in medical devices, not necessarily AI.

What the Document Does Provide Regarding Performance and Equivalence:

1. Acceptance Criteria (Implicit via Substantial Equivalence):

   • The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices (K230097 and K220669). This means the device must have the same intended use, fundamental technological characteristics, and be as safe and effective as the predicate device(s).
   • Specific parameters compared (and found to be similar or within acceptable ranges) are listed in the tables. These implicitly act as performance criteria for demonstrating substantial equivalence. For example, energy density (Max 4.92 J/cm² for the subject vs. Max 5.0 J/cm² for predicate K230097), wavelength range, spot size, and output energy levels are compared.

2. Study Proving Device Meets Criteria (Safety and Performance Testing):
   The document outlines the following standard safety and performance tests performed to demonstrate safety and effectiveness, supporting the claim of substantial equivalence:

   • Biocompatibility Safety:

     • Tests performed: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Irritation).
     • Result: Passed.

   • Electrical Safety and EMC:

     • Tests performed: IEC 60601-1-2 (EMC), IEC 60601-1 (Basic Safety and Essential Performance), IEC 60601-1-11 (Home Healthcare Environment), IEC 60601-2-83 (Home Light Therapy Equipment).
     • Result: Passed.

   • Eye Safety:

     • Test performed: IEC 62471 (Photobiological safety of lamps and lamp systems).
     • Result: Not explicitly stated as "passed" but grouped with other passed tests under "Performance Data."

   • Software Verification and Validation:

     • Description: "Software documentation consistent with moderate level of concern was submitted... System validation testing... demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This suggests internal V&V activities rather than a clinical performance study.

Addressing the Specific Questions (where information is available or can be inferred):

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

   Acceptance Criterion (Implicit for SE)	Reported Device Performance (Subject Device)	Predicate Device K230097
   Intended Use	Removal of unwanted body hair (OTC)	Same
   Mode of Action	IPL	Same
   Applicable Skin Type	Fitzpatrick Skin Type I-V	Same
   Wavelength range	510~1200nm	470~1200nm
   Energy density	Max 4.92 J/cm²	Max 5.0J/cm²
   Spot size	3.3 +/- 0.25 cm²	3.0 cm² +/- 0.5 cm²
   Output energy	Level 1: 6.0J to Level 5: 12.5J (±20%)	Range in 5~12.5J (±20%)
   Output energy level	1 to 5 level	5 level
   Pulse duration	5.84~9.24ms	4~10ms
   Biocompatibility	Met ISO 10993-5, -10, -23	Not explicitly detailed but implied similar for SE
   Electrical Safety/EMC	Met IEC 60601-1-2, -1, -11, -2-83	Not explicitly detailed but implied similar for SE
   Eye Safety	Met IEC 62471	Not explicitly detailed but implied similar for SE

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a clinical or AI/ML performance test set, which is not detailed here. The tests mentioned are laboratory safety and performance tests for the physical device itself.

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 or expert review is described.

4. Adjudication method for the test set: Not applicable.

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 not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Safety and performance tests against recognized standards are used, not clinical ground truth in the AI/ML sense.

8. The sample size for the training set: Not applicable. There is no mention of an AI/ML training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical Intense Pulse Light device, not an AI/ML medical device. Therefore, the detailed AI/ML performance study criteria requested are not present in this submission. The "performance data" section refers to standard electrical, biocompatibility, and eye safety testing necessary for the physical device's regulatory clearance.

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