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

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (PL), and it has been designed 3 models with the same IPL technology for hair removal, which is model JM-843, M-865, JM-638. The device 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 is by finger switch. IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200m and 500-1200m. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores thermal relaxation time but sparing normal skin by limiting the thermal relaxation time for skin.

This document does not contain information about acceptance criteria for a device's performance in a clinical study for hair removal, nor does it describe a study proving the device meets such criteria.

The provided text is an FDA 510(k) summary for an IPL Hair Removal Device (models JM-843, JM-865, JM-638). This summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

• Comparison of technological characteristics: This involves comparing specifications like wavelength, energy density, spot size, pulse duration, and power supply.
• Performance data from bench testing: This includes biocompatibility, electrical safety, EMC, eye safety, software verification, and a "Verification Report of Times of Flash" (service life of the lamp tube).

The document does not include:

• Clinical acceptance criteria for hair removal efficacy (e.g., percentage of hair reduction after a certain period).
• Results from a clinical study on human subjects to evaluate hair removal performance.
• Details about a test set (sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods) for assessing hair removal efficacy.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance for hair removal.
• Details about a training set for an AI/algorithm related to hair removal efficacy.

The "Performance Data" section primarily addresses safety and technical performance aspects of the device, not its biological effectiveness in hair removal on humans. The conclusion states that "the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device," but this "effectiveness" is primarily inferred from the similarity of technological characteristics to predicate devices that are presumably already accepted for hair removal.

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