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

Is Theradome FDA cleared and approved?

The Theradome helmets are FDA cleared for both men and women.

An FDA clearance is required for Class II medical devices, such as hair growth laser helmets. The FDA does not “approve” medical devices but clears them. The term “FDA approved” is not recognized by the FDA and has been a misused term by the media.