The purpose of the FDA 510(k) 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.
Due to the value of your Theradome, we require a signature for all deliveries. We use UPS for shipment and cannot ship to P.O. boxes. We can ship to residences, businesses and local UPS store facilities. If you would like to make a request to UPS regarding delivery options, using your tracking I.D, you can do so at www.ups.com
Orders placed before 11:30 AM PST on a business day (Monday – Friday) will generally ship out from our warehouse the same day. Orders placed after 11:30 AM PST or on a non-business day will ship from our warehouse the next business day.
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.
CEO and inventor Tamim Hamid, a former NASA Kennedy Space Center biomedical engineer, created and founded Theradome. After struggling with hair loss and 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 the development of unique, proprietary lasers designed to reduce hair loss and grow 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, the Theradome was perfected and is now the first over-the-counter (OTC) FDA cleared, clinical grade, wearable hair loss treatment device.
The company 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 the launch, providing 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.
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. https://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. https://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 https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171775.pdf
18 May 2018
Theradome LH40 EVO
The Theradome LH40 (Theragrow) 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 https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180460.pdf