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IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

The IPL sapphire cooling hair remove device 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 device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

This document describes the safety and performance testing for the "IPL sapphire cooling hair remove device" (Model: LB06) by Shenzhen Desida Technology Co., Ltd. for its 510(k) submission (K221635). The testing primarily focuses on safety rather than clinical efficacy for hair removal, as the device is determined to be substantially equivalent to previously cleared predicate devices for its intended use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility Safety:
   - ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity	Passed
   - ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization	Passed
   Electrical Safety:
   - IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility	Passed
   - IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance	Passed
   - IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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	Passed
   - IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment	Passed
   Eye Safety:
   - IEC 62471 Photobiological safety of lamps and lamp systems	Passed
   Software Verification and Validation:	All software requirement specifications met; all software hazards mitigated to acceptable risk levels.

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not explicitly state the sample size for any clinical test set, as the performance data provided focuses on laboratory and engineering safety tests (biocompatibility, electrical safety, eye safety, and software validation). No clinical study on human subjects is detailed for the subject device to prove its hair removal efficacy, likely due to substantial equivalence to predicate devices already cleared for that indication. The tests mentioned are likely conducted in a lab environment in China, given the manufacturer's location. The provenance is internal company testing to meet international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable (N/A) for the types of tests described. These are standardized engineering and biological safety tests, typically evaluated against established international standards rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:
   N/A. The evaluation methods for these standards are defined within the standards themselves, not through an adjudication process among experts in the context of this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
   No MRMC comparative effectiveness study was done or reported in this document. The submission relies on substantial equivalence to predicate devices for its intended use, rather than a direct clinical comparative effectiveness study against human readers or other devices for improved performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
   A standalone software validation was done, demonstrating that "all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." This is a standalone assessment of the device's software function, not a standalone clinical performance study.

7. The Type of Ground Truth Used:
   For the safety tests (biocompatibility, electrical, eye), the "ground truth" is defined by the specific requirements and pass/fail criteria outlined in the referenced international standards (e.g., ISO 10993-5, ISO 10993-10, IEC 60601 series, IEC 62471). For software, the ground truth is the "software requirement specifications." There is no clinical "ground truth" (like pathology or outcomes data) mentioned for hair removal efficacy for this specific device in this document, as it relies on substantial equivalence for that claim.

8. The Sample Size for the Training Set:
   N/A. As this document describes evaluation for substantial equivalence through safety and engineering tests, there is no mention of a "training set" in the context of machine learning or AI models for clinical outcomes. The device is an IPL hair removal device, not an AI diagnostic tool.

9. How the Ground Truth for the Training Set Was Established:
   N/A for the same reasons as #8.

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