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Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.

Here's an analysis of the provided text regarding acceptance criteria and studies demonstrating device performance:

Unfortunately, the provided document does not contain information about acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity) of a diagnostic or AI-driven device, nor does it describe a study proving the device meets such criteria.

The document details a 510(k) premarket notification for a Diode Laser Hair Removal device (LHR-V6S-1064, LHR-V6S/B-1064). The focus of this submission is on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, indications for use, and non-clinical safety testing.

Here's a breakdown of why the requested information isn't present and what information is provided:

Key Takeaways from the Document:

• Device Type: It's a physical medical device (laser for hair removal), not a diagnostic or AI-powered software device.
• Regulatory Pathway: 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive performance studies against specific acceptance criteria.
• No Clinical Study: The document explicitly states: "No clinical testing has been performed." This directly indicates that there aren't clinical performance metrics or studies to assess against acceptance criteria.
• Focus on Substantial Equivalence: The primary goal of the submission is to show that the proposed device is "as safe, as effective, and performs as well as or better than the predicate device" based on design, specifications, and non-clinical tests.

Response to your specific questions based on the provided document:

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

   • N/A. The document does not define specific performance acceptance criteria for a diagnostic or AI algorithm, nor does it report performance metrics against such criteria. The "performance testing" mentioned (Appearance, Function, Safety, Label, Shelf Life, Cleaning and Disinfection) are general bench tests for a physical device, not performance metrics like sensitivity or accuracy for a diagnostic.

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

   • N/A. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) is mentioned because "No clinical testing has been performed."

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):

   • N/A. No clinical test set requiring ground truth established by experts is mentioned.

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

   • N/A. No clinical test set requiring adjudication 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:

   • N/A. This device is for hair removal, not a diagnostic tool with AI assistance for human readers. No MRMC study was conducted.

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

   • N/A. This is a physical laser device, not an algorithm.

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

   • N/A. No clinical ground truth is established as no clinical studies were performed.

8. The sample size for the training set:

   • N/A. This refers to a dataset for training an algorithm. This device is not an AI algorithm.

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

   • N/A. As above, this is not an AI algorithm.

Information that is available about device equivalence and non-clinical testing:

• Non-Clinical Tests Submitted:
  • Biocompatibility Testing: According to ISO 10993-1:2018, including in vitro cytotoxicity (ISO 10993-5:2009), skin sensitization (ISO 10993-10:2021), and irritation (ISO 10993-23:2021). These tests were performed for parts contacting intact skin.
  • Electrical Safety and Electromagnetic Compatibility Testing: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22, and IEC 60825-1.
  • Software Verification and Validation: Performed according to FDA guidance for software in medical devices.
• Concise summary for performance testing (Bench Tests):
  • Appearance, Function, Safety, Label.
  • Shelf Life Test (accelerated aging).
  • Cleaning and Disinfection Verification.

In summary, the provided document is a 510(k) clearance for a laser hair removal device, focusing on demonstrating substantial equivalence through technical specifications and non-clinical safety tests, not clinical performance against specific acceptance criteria for a diagnostic or AI device.

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