Is Laser Hair Growth Safe? Side Effects and Who It's Not For
At-home laser hair-growth devices have a reassuring safety record in trials, but they're not for everyone. Here's what's known, what isn't, and who should check with a doctor first.
Key takeaways
- In controlled trials, side effects were mild and short-lived: scalp tenderness, itch, dryness, warmth, tingling or a little acne.
- Don't use one if you have a light-sensitivity condition or scalp cancer, or if you're under 18.
- The iRestore Elite is cleared for women with mild-to-moderate pattern loss (Ludwig I–II) and skin types I–IV only.
- The AAD notes long-term safety and effectiveness are still being studied.
What the trials found
A 2021 meta-analysis pooled 7 double-blind, sham-controlled trials of FDA-cleared home laser devices. Adverse events were mild, and included scalp tenderness, itching, dry skin, a sensation of warmth, acne and headache. [1] In one trial of a laser helmet in women, no adverse events were reported. [2]
These devices use low-power red light (the Elite runs at 625–680 nm, 5 mW per diode). That is not the high-power laser used to remove hair or resurface skin, and it doesn't burn or cut.
Who should not use one
From the iRestore Elite's safety instructions, as published by an authorised reseller:
- Anyone under 18.
- Anyone with a condition that makes the skin sensitive to sun or light, or who is allergic to light around 640–665 nm.
- Anyone with cancer on the scalp.
Also ask your doctor first if you take medication that can increase light sensitivity, if you're pregnant (we found no device-specific pregnancy guidance), or if you have any scalp condition.
Using it safely
- Don't look into the lasers, especially through magnifiers. The Elite's lasers are Class 3R.
- Use it on dry hair, away from water.
- Stop and see a doctor if itching or tingling lasts more than an hour after a session.
- Keep the device away from children and pets.
What "FDA-cleared" means, and doesn't
The iRestore Elite was cleared through the FDA's 510(k) process (K222081, October 2022) as a Class II over-the-counter device. Clearance means the FDA found it substantially equivalent to devices already on the market. The submission relied on non-clinical testing (electrical safety, biocompatibility, software and similar), not a new clinical trial. [3]
"Cleared" is not the same as "approved". Approval is the stricter pathway used for drugs such as minoxidil. The clearance also defines who the device is for: in women, androgenetic alopecia at Ludwig I–II, on Fitzpatrick skin types I–IV. [3] The AAD notes that long-term safety and effectiveness of laser devices are still being studied. [4]
See a doctor first if…
- your hair loss is sudden, patchy, or includes your eyebrows or front hairline
- your scalp is itchy, burning, red or scaly
- you haven't had thyroid, iron and vitamin D checked recently
- your scalp is largely see-through on top (Ludwig III), where iRestore says severe loss may not benefit
More on telling these apart: why hair thins after menopause.
Cleared for you? Take a closer look
If you have gradual thinning on top and skin types I–IV, the iRestore Elite matches its clearance. Explore it in 3D.
See it in 3D Shop at iRestore ↗Affiliate link: we may earn a commission if you buy, at no extra cost to you.
References
- Lueangarun S, et al. Efficacy and safety of low-level light therapy for androgenetic alopecia: a meta-analysis. J Clin Aesthet Dermatol, 2021. PMC8675345
- Lanzafame RJ, et al. The growth of human scalp hair in females using visible red light laser and LED sources. Lasers Surg Med, 2014. PubMed 25124964
- U.S. FDA 510(k) K222081, iRestore Elite (ID-510), decision summary. accessdata.fda.gov
- American Academy of Dermatology. Female pattern hair loss: diagnosis and treatment. aad.org