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IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent har reduction 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 .

The proposed device is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction
Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories.

This document is an FDA 510(k) summary for the IVYLASER Handhold Hair Removal Machine. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

The document states: "No clinical study is included in this submission." (Section 7. Clinical Test Conclusion).

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not available in this document. This submission relies on "Non clinical tests" and "Substantially Equivalent (SE) Comparison" to a predicate device to demonstrate safety and effectiveness.

Here's why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table 1 from your prompt): Clinical performance data proving the device meets specific outcome-based acceptance criteria (e.g., a certain percentage of hair reduction) is not provided since no clinical study was performed. The non-clinical tests relate to electrical safety, EMC, laser safety, and biocompatibility, not direct efficacy measurements on human subjects.
• Sample Size and Data Provenance for Test Set: No clinical test set.
• Number of Experts and Qualifications for Ground Truth: Not applicable as there's no clinical data requiring expert consensus or ground truth establishment from patient outcomes.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable, as there was no study involving human readers or AI assistance in a clinical setting.
• Standalone Performance: No clinical performance data is presented, so no standalone algorithm performance.
• Type of Ground Truth: Not applicable, as no clinical ground truth was established for efficacy.
• Sample Size for Training Set: Not applicable as this is a physical device, and the submission doesn't describe an AI/ML component or a training set in the context of clinical efficacy for hair removal.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of Device Features and Comparison (from the provided text, not directly answering your prompt):

The device, IVYLASER Handhold Hair Removal Machine, is intended for adjunctive use with shaving for hair removal and for permanent hair reduction, defined as long-term, stable reduction in regrowing hairs measured at 6, 9, and 12 months post-treatment.

Non-Clinical Tests Conducted (from Section 6):

• IEC 60601-1 (Medical electrical device - General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60825-1 (Safety of laser products - Equipment classification & requirements)
• ISO 10993-5 (Biological evaluation of medical devices - In Vitro cytotoxicity)
• ISO 10993-10 (Biological evaluation of medical devices - Irritation and delayed-type hypersensitivity)
• ASTM D4169-2016 (Transportation test) and shelf life verification test.

Substantial Equivalence (SE) Claim (from Section 9 & 10):

The applicant claims substantial equivalence to the SILKPRO Laser Hair Removal System (K142845) based on:

• Same Intended Use/Indications for Use: Both are OTC devices for hair removal and permanent hair reduction.
• Similar Technological Characteristics: Both are diode lasers operating around 808-810nm.
• Differences Discussed and Justified as Not Affecting SE: Wavelength (808nm vs 810nm), energy density (proposed device has lower max energy and different range), laser beam size (proposed device has larger beam), pulse width, frequency, and operating/storage environment. The document argues that despite these differences, the device's safety and effectiveness are not affected, primarily citing compliance with IEC 60825-1 and lower energy density of the proposed device. All noted differences were deemed not to raise new questions regarding safety or effectiveness.

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