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Everything you ever wanted to know about Theradome and laser hair growth!



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.

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:

510(K) # Approval Date Device Intended Use Statement
K122950 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
K161046 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
K171775 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
K180460 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