What Does the FDA Say About Laser Hair Removal?

Brian Lett
By Brian Lett
10 Min Read

what does the FDA say about laser hair removal

Laser hair removal is a safe, effective way to rid unwanted body hair. It can improve both appearance and self-confidence by eliminating excess hair caused by medications, hormones or other sources.

Any laser device marketed for hair removal must receive FDA clearance, and it’s essential that users understand how this approval works.

510(k) Clearance

Lasers used for hair removal are medical devices and therefore must undergo the FDA’s 510(k) clearance process in order to be legally sold in the US. To meet this standard, manufacturers must submit a premarket notification showing their device is substantially equivalent to another legally-marketed device (the “predicate”).

If the 510(k) process is successfully completed, your device will receive its own unique number and be included in the FDA’s medical devices database – this data can then be searched using simple web queries.

While a device may have been cleared by the FDA, that does not indicate any particular approval from them for any particular use. Consumers frequently make this assumption when researching laser hair removal devices and other consumer products that have medical or aesthetic purposes; many websites and publications often refer to laser hair removal products with references like ‘FDA approved’ when speaking about them whereas, more accurately and often seen on consumer products of medical or aesthetic nature is ‘FDA cleared’ instead.

The 510(k) clearance process is an invaluable way to safeguard patients. However, it is essential to recognize that some devices can still pose danger if used incorrectly – for instance if an operator uses laser treatment on an unintended patient and doesn’t calibrate each laser according to intended operation then this could pose significant hazard to both skin and eye tissue.

Therefore, it is crucial that a qualified and experienced laser technician carry out your treatment. An experienced technician will ensure the device operates as intended and advise you as to when and for how long treatments should take place.

Not only should you make sure that the device and laser technician you choose are safe, but it is equally essential to do your own research when it comes to getting optimal results from treatment. One effective way is checking the FDA 510(k) database to see if their approval for your specific indication.

Precautions

Laser hair removal employs a laser beam to destroy pigment in hair follicles and prevent future growth of unwanted hair. Treatment sessions usually last anywhere from several weeks to several months depending on the area being treated and an individual’s skin response; to decrease risks of complications following laser sessions it is vitally important that patients adhere to physician guidelines regarding post-treatment care.

Oregon Health & Science University suggests avoiding direct sunlight on treated areas until instructed by your physician to do so, since tanning your skin can reduce laser hair removal’s effectiveness and increase risks such as hyperpigmentation. If necessary, always wear sunscreen with an SPF 30+ rating when going outdoors to safeguard treated skin from sunburns.

Prior to beginning laser hair removal treatments, it’s essential that the area being treated be shaved, as this allows laser light to penetrate more readily. Furthermore, tanning beds should also be avoided during this time as tanning interferes with laser’s ability to work effectively on hair removal.

If you have dark skin, be sure to ask your physician if they have experience performing laser hair removal on those with darker complexions. Certain medicines, including spironolactone, Diane-35 birth control pills and Euflex, Androcur and Vaniqa creams may decrease contrast between your skin color and hair color, rendering laser treatment less effective.

At your appointment, protective eyewear or goggles may be worn to shield your eyes from laser light radiation. Your doctor may apply topical anesthetic for any discomfort and will likely use the laser on a treatment area which was shaved prior to your visit – this ensures the best possible results tailored to your unique skin type and situation. It often requires multiple sessions before reaching desired results on fast-growing body areas like face and bikini line areas.

Side Effects

Laser hair removal can be a lifesaver for many. It helps them overcome insecurities about their appearance while relieving them of hours spent shaving. But before diving headfirst into this permanent solution for hair growth, make sure the procedure is safe for you; there have been reports that some forms can increase cancer risks and even cause infertility!

Laser hair removal generally produces only minor, short-lived side effects. Most commonly reported are an itchy sensation immediately following treatment and temporary redness of the skin afterward – both effects caused by laser light passing through skin to target pigmented hair follicles and reduce hair growth. Some laser instruments come equipped with cooling devices or gel to minimize discomfort and minimize potential side effects.

After laser hair removal, you may become sensitive to sunlight. Therefore, it is crucial that when going outdoors after treatment you wear sunscreen so as to prevent sun damage and sunburn or other adverse health consequences from the sun’s UV rays.

Alterations to skin pigmentation may also occur; this typically affects individuals with darker skin tones and could be the result of using an unsuitable type of laser or improper treatment procedures. A chemical peel can also help fade pigment from treated areas after laser treatment has taken place.

Select a medical doctor with extensive dermatology knowledge who specializes in laser treatments to perform your laser treatments. A dermatologist can identify complications that might arise during and after treatments; inexperienced practitioners could lead to scarring and other harmful side effects from laser treatment; therefore it’s crucial that only equipment that has been approved by the FDA as safe for at-home use be used.

Results

Laser hair removal involves sending pulses of light into the treatment area in order to damage hair follicles and leave them unable to produce new hairs, leading them to fall out or be pushed up by skin pressure. Most people begin seeing results within the first treatment session but up to eight sessions may be necessary before reaching desired results based on skin color, thickness, hair follicle activity levels and location on body.

Laser hair removal is generally safe and effective when performed by licensed professionals. Although possible side effects, such as pigment changes (darkening or lightening of skin pigment), blistering, scarring or infection, may arise, these should only occur rarely when handled by experienced dermatologists.

Prior to beginning laser hair removal, it’s important to become informed of its risks and consult your physician regarding them. Also, ensure that no medications cause side effects; avoid sun exposure and sunless tanning creams at least one week prior to treatment.

Some of the side effects of laser hair removal may be more severe if you have darker skin as the laser cannot differentiate between pigmented and non-pigmented hairs. Furthermore, women experiencing hormonal imbalances often see slower or reduced reduction as the laser cannot target emerging hairs directly.

Due to the risk of complications associated with laser safety inspections and interviews with operating personnel, guidelines were developed for those using these devices in salons or spas in order to reduce health risks for both customers and operating personnel. These regulations aim to minimize health risk exposure in this way.

As part of your laser hair removal sessions, it may become apparent that the treated area becomes red and swollen afterward. Applying cold compresses, using an anti-inflammatory cream and avoiding sunlight are all great ways to ease these symptoms; typically they will resolve shortly post treatment.

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