The shipping charge paid by customers with shipping addresses outside of the U.S. covers the cost of shipping only. Customers with shipping addresses outside of the U.S. are solely responsible for all duties, import taxes and brokerage fees. These are not included in the cost of shipping or handling of your order. Customs, duties, and taxes vary from country to country; please check with your local customs agency for details on estimated costs.
Please also note that customs, duty, and taxes are non-refundable. If you refuse a shipment because of unexpected import fees, the cost of the original shipping, any brokerage/customs/duty/taxes, and any return shipping charges cannot be refunded.
Theradome was based on the finding of Endre Mester. Mester was a Hungarian physician who accidentally discovered that lasers can grow hair in mice in 1965. That information sat dormant until about 2009 when we discovered that the same wavelength of 680 nanometers was able to grow hair on humans. The 680nm wavelength is important for deep penetration of hair follicles.
Theradome CEO and inventor Tamim Hamid, a former NASA Kennedy Space Center biomedical engineer, created and founded Theradome. Tamim struggled with hair loss. He became frustrated with the ineffectiveness, high cost, and inconvenience of available products on the market. He became determined to develop a solution to hair loss that was safe, effective, affordable, and convenient to use.
Tamim Hamid applied his extensive scientific knowledge of medicine and engineering to develop a solution. Theradome is a unique device with proprietary lasers that reduces hair loss and grows hair.
After assembling a team of practicing hair loss specialists, technology experts, and skilled engineers, the team developed a next-generation hair restoration device. After extensive design and testing, Theradome was perfected. It is now the first over-the-counter (OTC) FDA cleared, clinical grade, wearable hair loss device.
Theradome was officially launched in August 2013. Start-up funds were raised through a crowd funding initiative on Indiegogo.com. Fundraising goals were accomplished within 24 hours of launch. This was a strong indication of the consumer demand for the product.
The demand and satisfaction with Theradome are extremely high on both consumer and professional ends of the market.
The PRO was FDA cleared on June 2013 for women and the EVO was FDA cleared for women on May 2016. The Theradome PRO and EVO were cleared on January 2018 for men.
The purpose of the FDA clearance is to validate the safety and effectiveness of a medical device. To protect people from false claims and dangerous medical equipment, the United States requires rigorous testing that includes laboratory and clinical trials to prove both safety and effectiveness. Data derived from these studies, which must meet specific requirements, are submitted to the FDA via a 510(k) submission form for review and clearance to legally market the medical device.
An FDA 510(k) clearance allows consumers to distinguish between proof and false claims concerning safety and efficacy. Only after gaining clearance–the acknowledgement that the device is safe and effective for public sale–is an FDA 510(k) clearance granted to the manufacturers of a medical device.
It is very important that any device you consider for purchase is FDA cleared. We advise you to visit the FDA.gov website to check for a product’s FDA compliance status before reaching a decision.
Our official FDA clearance letters can be seen on the FDA website at:
Intended Use Statement
14 June 2013
Theradome LH80 PRO
The Theradome Laser Helmet LH80 PRO is an over-the-counter (OTC) device indicated to treat androgenetic alopecia, to promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV. www.accessdata.fda.gov/cdrh_docs/pdf12/K122950.pdf
12 May 2016
Theradome LH40 EVO
The Theradome Laser Helmet LH40 EVO is an over-the-counter (OTC) device indicated to treat androgenetic alopecia, to promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV. www.accessdata.fda.gov/cdrh_docs/pdf16/K161046.pdf
09 January 2018
Theradome LH80 PRO
The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV www.accessdata.fda.gov/cdrh_docs/pdf17/K171775.pdf
18 May 2018
Theradome LH40 EVO
The Theradome LH40 is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV www.accessdata.fda.gov/cdrh_docs/pdf18/K180460.pdf