Home / Companies / Theradome, Inc.
5 FDA records filed under this company name, from 2012 to 2018, in hair growth (OAP, 5).
The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
510(k) cleared
Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.
510(k) cleared
“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.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.
510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
Not quoted here. FDA's PDF for this record is a scanned image with no text, so we can't quote it. Read FDA's PDF.
510(k) cleared
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 5.