Was Theradome FDA Cleared and When?
The PRO was FDA cleared in June 2013 for women and the EVO was FDA cleared for women in May 2016. The Theradome PRO and EVO were cleared in January 2018 for men.
| 510(K) # | Approval Date | DEVICE | Intended Use Statement | |
|---|---|---|---|---|
| K122950 | 14 June 2013 | Theradome PRO LH80 |
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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 EVO LH40 |
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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 PRO LH80 |
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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 EVO LH40 |
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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 |
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The Theradome® Hair Helmet Provides Next-Generation, Clinical Strength Laser Hair Technology for Safe, Effective Laser Hair Regrowth Treatments at Home
