The Hale Proof Center.
Health Canada Class II. FDA Registered. A curated clinical evidence library. Every document an operator or compliance reviewer asks for, in one place.
Each download captures contact information so we can ship registration certificate scans and supporting evidence on request. No marketing email cascade.
Health Canada Class II
Medical Devices Regulations classification — the regulatory floor required for active photobiomodulation devices used in Canadian clinical practice.
Open documentFDA Registered
U.S. Food and Drug Administration establishment registration and device listing under 21 CFR Part 807. Required for U.S. cross-border procurement.
Open documentCapability Statement 2026
One-page company snapshot — regulatory status, technical specifications, product family pricing, and procurement posture for RFP responses.
Open documentClinical Evidence Library
A curated library of clinical photobiomodulation evidence — pain, recovery, brain and mood, safety, mechanism, skin. Sortable by condition.
Open documentWhere the Proof Center fits
- Browsing for a single clinic? Start at the Clinic Deployment page — the Proof Center will arrive automatically in your confirmation email.
- Scoping a multi-site network? Use the Proof Center alongside /for-businesses and /enterprise.
- Looking for a specific clinical condition? Jump directly to the Clinical Evidence Library.