Is Laser Therapy Safe to Use at Home, or Should It Always Be Done in a Clinic?

Low-level laser therapy (LLLT), also called photobiomodulation, is used for several purposes, but this page looks only at devices for pattern hair loss. Whether it is reasonable to use at home depends on the device, how it is used, and who is using it.

What Low-Level Laser Therapy Is

LLLT devices for hair loss deliver red light (usually around 650–680 nm) from low-power lasers or LEDs. Unlike surgical or hair-removal lasers, they are not meant to heat or cut tissue. The idea is that the light influences activity in hair follicle cells; this mechanism is still a hypothesis.

How Home Hair-Loss Devices Are Regulated in the US

Home hair-growth lasers (combs, caps and helmets) are FDA-cleared, not FDA-approved. They are Class II medical devices under 21 CFR 890.5500 (product code OAP). Clearance comes through the 510(k) process, which finds a device substantially equivalent to one already on the market; it is not an FDA measurement of how well the device works.

• The first clearance, in January 2007, was the HairMax LaserComb, for men with Norwood-Hamilton IIa–V hair loss (510(k) K060305).
• Later devices were cleared for women as well. For example, the iRestore helmet was cleared in January 2016 for women with Ludwig-Savin I–II and men with Norwood-Hamilton IIa–V hair loss (510(k) K151662).

What the Trials Say About Safety

The trials of home hair-loss devices were run with people using the devices themselves at home. In a 2014 multicenter, double-blind trial of the HairMax Lasercomb in 128 men and 141 women over 26 weeks, no serious adverse events were reported (Jimenez et al., 2014). The helmet trials in 44 men and 47 women over 16 weeks reported no adverse events (Lanzafame et al., 2013 and 2014). A 2021 meta-analysis of seven double-blind trials of home-use devices found greater increases in hair density with active devices than with sham devices, and called for longer follow-up studies (Lueangarun et al., 2021).

These trials were small and lasted 4 to 6 months, so long-term safety has not been studied.

Safety Precautions for Home Use

• Protect your eyes. Many home devices use Class 3R lasers. The FDA says lasers in this class can be momentarily hazardous to the eye when a person looks directly into the beam, so do not look into the light or point it at the eyes.
• Use only an FDA-cleared device, and use it as the label directs (time per session and number of sessions per week).
• Ask a doctor before use if you take medicines that make skin sensitive to light, or if you have a scalp condition, a scalp wound, or unexplained hair loss.
• Stop using the device and seek advice if your scalp becomes red, sore or irritated.
• Buy from a known seller. The FDA has warned about laser products sold online that may not meet safety standards.

Home or Clinic?

For pattern hair loss, the trials that led to these devices being sold were done with home use, so a clinic is not required to use them. A clinic visit is still useful to confirm the cause of hair loss before starting, because other conditions can look like pattern hair loss. Talk to a doctor or pharmacist before starting or changing a hair-loss treatment.

References

Jimenez, J. J., Wikramanayake, T. C., Bergfeld, W., Hordinsky, M., Hickman, J. G., Hamblin, M. R., et al. (2014). Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study. American Journal of Clinical Dermatology, 15(2), 115–127. https://pubmed.ncbi.nlm.nih.gov/24474647/

Lanzafame, R. J., Blanche, R. R., Bodian, A. B., Chiacchierini, R. P., Fernandez-Obregon, A., Kazmirek, E. R. (2013). The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lasers in Surgery and Medicine, 45(8), 487–495. https://pubmed.ncbi.nlm.nih.gov/24078483/

Lanzafame, R. J., Blanche, R. R., Chiacchierini, R. P., Kazmirek, E. R., & Sklar, J. A. (2014). The growth of human scalp hair in females using visible red light laser and LED sources. Lasers in Surgery and Medicine, 46(8), 601–607. https://pubmed.ncbi.nlm.nih.gov/25124964/

Lueangarun, S., Visutjindaporn, P., Parcharoen, Y., Jamparuang, P., & Tempark, T. (2021). A systematic review and meta-analysis of randomized controlled trials of United States Food and Drug Administration-approved, home-use, low-level light/laser therapy devices for pattern hair loss: Device design and technology. Journal of Clinical and Aesthetic Dermatology, 14(11), E64–E75. https://pubmed.ncbi.nlm.nih.gov/34980962/

U.S. Food and Drug Administration. 510(k) K060305, HairMax LaserComb (Lexington International), decision 18 January 2007, substantially equivalent; product code OAP. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K060305

U.S. Food and Drug Administration. 510(k) K151662, iRestore Hair Growth System (Freedom Laser Therapy), decision 6 January 2016, substantially equivalent. https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151662.pdf

U.S. Food and Drug Administration. Laser Products and Instruments. https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments

U.S. Food and Drug Administration. Consumer safety alert: Internet sales of laser products. https://www.fda.gov/radiation-emitting-products/alerts-and-notices/consumer-safety-alert-internet-sales-laser-products