Module 3 — Objective Evidence, FDA Clearances & Claim Verification
Category
Regulatory
Showing 6 of 6 audited entries · 3 carry no FDA clearance for hair loss.
iRestore · Laser cap
iRestore Professional Laser Cap
FDA 510(k) ClearedManufacturer-Funded Study
Claim vs. evidence audit notes3 of 3 qualified or unsupported
!Vendor claim6-month clinical trial: 43% density increase
Audit noteFigure originates from a manufacturer-funded study. Sample size, control arm and full protocol are not published in a peer-reviewed journal, so the effect size cannot be independently checked.
!Vendor claimFDA 510(k)-cleared Class II device
Audit noteClearance is verifiable and genuine, but 510(k) denotes substantial equivalence to a predicate device for safety. It is not an FDA finding of efficacy, and vendors routinely present it as though it were.
!Vendor claim282 laser diodes — 650 nm wavelength
Audit noteDiode count is a hardware specification, not a dose. Irradiance delivered at the scalp — the variable that determines outcome — is not disclosed.
Claim vs. evidence audit notes2 of 3 qualified or unsupported
!Vendor claimFDA-cleared for men and women
Audit noteClearance covers device safety and equivalence. It carries no comparative efficacy data between sexes, and none has been published for this device.
×Vendor claimIncludes 7-month growth guarantee
Audit noteA refund policy is a commercial term, not clinical evidence. It is presented alongside efficacy claims in vendor marketing.
✓Vendor claim30-min session, 3× / week protocol
Audit noteDosing schedule is consistent with published low-level laser therapy regimens. Real-world adherence — the main determinant of outcome — is not reported.
Claim vs. evidence audit notes2 of 3 qualified or unsupported
✓Vendor claimNo FDA hair-loss clearance (wellness use)
Audit noteDisclosure verified. The vendor states the regulatory position plainly rather than implying clearance — the correct behaviour, and worth crediting.
×Vendor claimEmerging evidence for follicle stimulation
Audit noteCited evidence comes from general photobiomodulation literature, not from scalp trials of this panel. No hair-loss study of this device was located.
!Vendor claimDual 660 nm red + 850 nm NIR output
Audit noteWavelengths are plausible for photobiomodulation, but no scalp-specific dosing protocol is published for this product.
Claim vs. evidence audit notes2 of 3 qualified or unsupported
✓Vendor claimPhase III: 83% halted loss at 2 years
Audit noteConsistent with the published finasteride trial record. The result belongs to the molecule and applies to any 1 mg generic — it is not a property of this vendor.
!Vendor claimInhibits Type II 5α-reductase (−70% scalp DHT)
Audit noteSupported by established pharmacology. Sexual side effects and post-finasteride reports are not disclosed alongside this figure in vendor copy.
Independence statement — RootAudit sells nothing, holds no inventory, and receives no commission, sponsorship, or placement fee from any manufacturer listed here. Outbound links carry nofollow sponsored noopenerand point to manufacturers' own pages so their claims can be read in full and checked against the audit notes above. FDA 510(k) clearance denotes substantial equivalence to an existing device for safety — it is not a finding of efficacy.