Device Regulatory Status
The FoLix Laser by Lumenis (Step 1) is an independently FDA-cleared medical device, reviewed and authorized through the 510(k) premarket notification pathway as a standalone protocol. FDA clearance indicates the device has been found substantially equivalent to a legally marketed predicate device; it does not constitute FDA endorsement of any combined protocol or service offering.
The Alma TED System (Step 3) is an FDA-registered Class I medical device. Most Class I devices, including the Alma TED, are exempt from 510(k) premarket notification and are subject to FDA general controls only. Registration with the FDA does not constitute clearance, approval, or endorsement of specific clinical claims. The underlying technology (transepidermal delivery assisted by acoustic sound waves) is supported by published peer-reviewed research and is protected by US Patent No. 10,238,849 B2.
The Alma TED System includes its own manufacturer-supplied proprietary TED+ Serum. No other substances beyond the manufacturer’s TED+ Serum are used with this system as part of The Root Method™.
Revian RED: At-Home Device
The Revian RED is an FDA-cleared at-home LED light therapy device (510(k) clearance K173729), cleared for androgenetic alopecia in Fitzpatrick Skin Types I to IV. Clinical data referenced (+26.3 hairs per cm²) is sourced from a randomized, double-blind, placebo-controlled clinical trial at ≥80% compliance over 16 weeks. This data is provided for informational purposes only. Individual results vary and are not guaranteed. The Revian RED is an optional at-home adjunct and is not a component of The Root Method™ in-clinic protocol.
Topical Serum, Supplements & Compounded Topicals
The Hair Lab Proprietary Hair Serum (Step 2) is a topical cosmetic hair serum developed independently of any device manufacturer. The Hair Lab holds an ownership position in the laboratory behind this serum. This product is not an FDA-cleared medical device and is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Statements regarding this serum have not been evaluated by the Food and Drug Administration.
Nutrafol™ is a physician-formulated nutritional supplement. Statements have not been evaluated by the FDA. Nutrafol™ is not intended to diagnose, treat, cure, or prevent any disease. Offered as an optional complement to the protocol.
Provider-prescribed compounded topicals, where offered, are formulated individually by licensed providers and are not part of the standard Root Method™ protocol. These are not FDA-evaluated products.
Individual Results & Protocol Positioning
Individual results vary. Hair rejuvenation outcomes depend on a wide range of biological, genetic, hormonal, and lifestyle factors. Statistics, clinical references, and before & after photography referenced on this page are provided for informational purposes only and do not constitute a guarantee of results for any individual.
The Root Method™ is a branded cosmetic aesthetic hair rejuvenation protocol offered exclusively at The Hair Lab, Lakeway, Texas. It is positioned as a non-invasive cosmetic aesthetic service and is not a medical treatment for hair loss, alopecia, or any other medical condition. The Root Method™ does not diagnose, treat, cure, or prevent any disease.