Guidelines on the safety of light‐based home‐use hair removal devices from the European Society for Laser Dermatology

Town, Godfrey; Ash, Caerwyn; Dierickx, Christine; Fritz, Klaus; Bjerring, Peter; Hædersdal, Merete

doi:10.1111/j.1468-3083.2011.04406.x

Cited by 25 publications

(24 citation statements)

References 50 publications

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“…Currently, the FDA requires compliance with certain standards and regulations for lightbased home-use devices sold in the United States. 49 These devices are based on IPL and laser technologies but operate at lower fluences than comparable in-office devices. The 810-nm diode Tria laser (Tria Beauty, Inc., Dublin, CA) and 475 to 1,200 nm IPL Silk'n device (Home Skinovations, Kfar Saba, Israel) are the current FDA-approved hair removal systems.…”

Section: Home-use Devicesmentioning

confidence: 99%

Laser Hair Removal: A Review

Gan

Graber

2013

Dermatologic Surgery

167

127

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Section: Home-use Devicesmentioning

confidence: 99%

Laser Hair Removal: A Review

Gan

Graber

2013

Dermatologic Surgery

167

127

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“…Clinical efficacy and safety of home‐use laser and IPL devices has also been scrutinised in several review studies including Haedersdal et al, Thaysen‐Petersen et al, and Town et al . Comparative reviews have been published by Hession et al, Hodson, Thomas et al, and Keller .…”

Section: Resultsmentioning

confidence: 99%

Light‐based home‐use devices for hair removal: Why do they work and how effective they are?

et al. 2019

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Objectives This review has the following objectives: Firstly, it provides an explanation of the evolution of laser/intense pulsed light (IPL) hair reduction modalities from high fluence professional devices to low fluence home‐use appliances. Secondly, it summarises published literature reviews on home‐use devices (HUDs) as evidence of their growing credibility. Thirdly, it proposes mechanistic differences in light delivery regimes and the resulting divergences in mode of action. Materials and Methods An extensive literature search was performed to review the progress of laser/IPL‐induced hair reduction and determine what evidence is available to explain the mode of action of professional and HUDs for hair removal. Establishing the likely biological mode of action of professional high‐fluence systems versus home‐use low‐fluence appliances was performed by combining data obtained using ex vivo hair follicle (HF) organ culture and the clinical results involving human participants. Results Significant basic science and clinical evidence has been published to confirm the clinical efficacy and technical safety of many laser and IPL home‐use devices for hair removal. Clearly, HUDs are different compared to professional systems both in terms of fluence per pulse and in terms of biological mechanisms underlying hair removal. Here we presented data showing that a single low fluence pulse of both 810 nm laser (6.6 J/cm2, 16 ms) and IPL (9 J/cm2, 15 ms and 6.8 J/cm2, 1.9 ms) leads to induction of catagen transition. Catagen transition was characterized by morphological changes similar to what occurs in vivo with occasional detection of apoptosis in the dermal papilla and outer root sheath cells. This suggests that high hair reduction can be expected in vivo and longer‐term treatment might result in HF miniaturization due to a cumulative effect on the dermal papilla and outer root sheath cells. In line with this hypothesis, in this review we demonstrate that long‐term application of a commercially‐available home‐use IPL appliance resulted in persistent hair reduction (80%) one year after last treatment. These data are in line with what was previously reported in the literature, where clinical studies with home‐use IPL appliances demonstrated high efficacy of hair reduction on female legs, armpits and bikini zones, with full hair regrowth after four treatments following cessation of IPL administration. Limitations of HUDs include lack of hair clearance for very dark skin types and low speed of treatment compared with professional devices. Numerous uncontrolled and controlled clinical efficacy studies and technical safety investigations on consumer‐use appliances support many of the leading manufacturers' claims. Analysis & Conclusions Manufacturers make consumer appliances safe and easy to use by considering “human factors,” needs and capabilities of a variety of users. Safety is of primary concern to manufacturers, regulators and standards bodies as these appliances may be accessible to children or their use attempted on uns...

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“…This FDA recognition of the IEC standards has not yet been codified and in the interim, so as to reduce the regulatory burden on industry and the CDRH agency, FDA has released 'Laser Notice No.50' that explains which of the IEC standards will be accepted in the USA. This industry guidance allows some IEC standards for lasers to be accepted within the USA [18]. Hence, since 2007 FDA has accepted the new classification labelling.…”

Section: Laser Safety Standards and Hazard Parametersmentioning

confidence: 99%

Laser Safety Standards and Measurements of Hazard Parameters for Medical Lasers

Luca¹,

Delfino

Lepore³

2013

OPTICS

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Laser sources are nowadays largely adopted in medicine and hence they are widespread in medical environment, where patients are present and the users are not always highly specialized in managing laser sources. This has greatly boosted the attention towards safety issues related to exposure to laser beams and to strictly assess the values of well defined laser radiation standard parameters characterizing the level of hazard of laser sources. In this framework, we measured two of the most important parameters, Maximum Permissible Exposure (MPE) and Nominal Ocular Hazard Distance (NOHD), for some of the laser sources mostly employed in medicine. Additionally, we compared our results with data elaborated from standards in order to single out safe and comfortable working conditions. The results here reported have shown that information provided by manufacturers is often not enough to define the hazard level of the laser source and measurements of the main safety parameters are mandatory.

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Guidelines on the safety of light‐based home‐use hair removal devices from the European Society for Laser Dermatology

Cited by 25 publications

References 50 publications

Laser Hair Removal: A Review

Laser Hair Removal: A Review

Light‐based home‐use devices for hair removal: Why do they work and how effective they are?

Laser Safety Standards and Measurements of Hazard Parameters for Medical Lasers

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