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MED-FDA-CLEAREDBoundedlegally required
Devices are described as cleared, not approved
What the source requires
Most aesthetic energy devices reach market through 510(k) clearance rather than approval, and registration and listing do not denote approval.
Why this is hard to satisfy
Vendor marketing copy is reproduced verbatim, and staff have no reference distinguishing a cleared device from an approved drug.
What we do about it
Claims are checked against a sourced device-to-pathway reference. Genuinely approved products are recognised as such rather than flagged.
In build · phase two
What this tier means
Formal reasoning over a bounded policy. Sound only for what the policy models, so we say “checked against”, never “guaranteed”.