Why is an FDA 501(k) clearance important?


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.

Shipping charge inclusions for international orders outside of USA


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.

Information on Tamim Hamid, the Theradome inventor and creator


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.

Do you accept check payments?


We do accept checks mailed to the following address:

Theradome Inc.
4900 Hopyard Rd,  Suite 100
Pleasanton CA 94588

Please note that it can take 1 to 2 weeks once received to process the payment and ship your order.  Credit card, PayPal and the Affirm payment option all process immediately through the website.

Is Theradome safe? When was Theradome FDA cleared?


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.

 

510(K) #Approval DateDeviceIntended Use Statement
K12295014 June 2013Theradome LH80 PROThe 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
K16104612 May 2016Theradome LH40 EVOThe 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
K17177509 January 2018Theradome LH80 PROThe 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
K18046018 May 2018Theradome LH40 EVOThe 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