FDA Registered vs. FDA Cleared: What It Means for a Red Light Therapy Bed
FDA registration means a company and its device are listed with the FDA; it is not an approval or clearance. FDA 510(k) clearance means the FDA reviewed the device for a specific intended use. The Trifecta Light PRO 450 is FDA cleared for both fat loss and healing.
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The difference at a glance
- Registered: the company and device are listed with the FDA. Not an approval or clearance.
- Cleared (510(k)): the FDA reviewed the device for a specific intended use and found it substantially equivalent to a legally marketed device.
How to check any bed
- Ask the manufacturer for documentation of its registration and the device’s clearance.
- Confirm the status directly in the FDA database, and check that the cleared intended use matches how you plan to use the bed.
PRO 450 at a glance
- FDA cleared for fat loss and healing
- 5,016 LEDs above and below; combined red and near-infrared wavelengths, up to 150 mW/cm²
- 10 to 12-minute full-body session; front and back at once, no turning over
- 3 to 4 clients an hour, 7 days a week
- 6′8″ long × 3′1″ wide; 220V on a dedicated 30-amp circuit
- 5-year limited warranty on the bed; lifetime warranty on the LEDs
- One-on-one expert training for every provider
Questions
Is the Trifecta Light PRO 450 FDA approved?
It is FDA cleared, not approved: the PRO 450 is FDA cleared for fat loss and healing through the 510(k) process.
Are other full-body red light beds cleared for fat loss and healing?
The PRO 450 is the only full-body red light therapy bed FDA cleared for both fat loss and healing.
Request pricingCall (800) 691-4085
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