Before your clinic sells a device, know what you can safely claim about it.
AuditGPT reviews device pages, supplier claims, FDA-status language, evidence gaps, and AI answer risk for red light, hair-growth, PEMF, body-contouring, EMS, RF microneedling, and aesthetic-device offers.
Not legal, regulatory, FDA, import, customs, or clinical advice. Claim language and evidence review only.
Why device claims are risky
Cleared for a specific use — marketed for everything.
FDA 510(k) clearance applies to a specific device, for a specific intended use, in a specific patient population. When clinics and suppliers market those same devices for broader uses — "tightens all skin," "eliminates fat permanently," "reverses aging" — the claim has moved past what the clearance supports.
AI search engines then crawl those pages and repeat the overclaim in AI-generated answers to patient questions — creating a second layer of distortion that the clinic cannot directly edit.
Cleared ≠ approved ≠ safe for all
FDA "clearance" through 510(k) means a device is substantially equivalent to a predicate. It does not mean FDA approved the treatment outcome, the patient population, or every marketed application.
"Non-invasive" is often inaccurate
RF microneedling uses needles that penetrate skin. Laser treatments create thermal injury. "Non-invasive" applied to these procedures can be directly inaccurate.
EMS weight-loss is a red-zone category
Girth reduction, fat elimination, or weight-loss outcome claims applied to EMS devices frequently outrun the cleared indication and available evidence.
Exosome products have no FDA approval
FDA public safety notices state there are no FDA-approved exosome products for any use. Marketing them as "FDA-reviewed regenerative therapy" is not supportable.
Category risk matrix
Not all device categories carry the same claim risk.
This matrix reflects the current claim-review risk profile, not FDA clearance status. A green-tier device can still have individual claims that require rewrite.
Hair-growth laser caps and helmets
FDA 510(k)-cleared devices exist in this category for specific androgenic alopecia indications. Claims must match cleared indication and population exactly.
Selected red-light therapy products
Where specific evidence exists for a specific use and device, careful claim framing is possible. Evidence must be product-specific, not category-level.
PEMF mats
Some cleared indications exist. Claims must be restricted to cleared uses; wellness and anti-aging positioning requires careful framing.
Body-contouring-adjacent devices
Fat-reduction claims must cite specific cleared device, specific indication, and avoid weight-loss or permanence framing.
General wellness red-light positioning
Broad "wellness" framing is defensible only when claims are evidence-backed, device-specific, and do not imply treatment of disease.
RF microneedling
FDA safety notices have highlighted serious adverse events. "No downtime," "painless," and "safe for everyone" language requires specific patient-selection and risk disclosures.
EMS weight-loss or girth-reduction claims
Claims implying weight loss, fat elimination, or permanent girth reduction from EMS devices are a red-zone category. These claims lack adequate substantiation for most marketed outcomes and are a documented FTC/FDA concern.
Exosome or stem-cell products marketed as approved therapies
FDA public safety notices state there are no FDA-approved exosome products for any use. Marketing these as approved, clinical, or disease-treating is directly contradicted by public FDA guidance.
Any device claiming to cure, treat, reverse, or prevent disease
Drug or disease claims on devices require FDA approval or clearance for that specific indication. "Reverses aging," "cures acne," "treats depression" applied to devices without FDA clearance creates significant regulatory exposure.
Compounded drug + device combination claims
If a device claim is bundled with a compounded drug claim, both layers of risk compound. Treat each claim surface separately.
What gets reviewed
Seven claim surfaces reviewed on every device page.
Supplier claim language
Public claims made by the supplier or manufacturer, including catalogs, websites, and sales materials.
FDA-status language check
Whether 510(k) clearance numbers, cleared indications, exemptions, or registration data are accurately reflected in marketing language.
Cleared indication vs. marketed use
Whether the specific use being marketed matches the specific use the device was cleared for — these often diverge.
Before/after gallery claims
Result implication language, typicality disclosure, and outcome framing in device before/after galleries.
Safety and downtime claims
"No downtime," "painless," "non-invasive," and "safe for all skin types" language reviewed against device labeling and adverse-event disclosures.
AI answer distortion
Whether AI search engines repeat inaccurate device claims or FDA-status language from your public pages.
Supplier diligence materials
Where provided: QMS documentation, test reports, 510(k) numbers, labeling files, and country-of-origin marking.
Device Evidence Pack
A structured record of what the device can and cannot claim.
The Device Evidence Pack documents the claim-review process for a specific device — what the supplier claims, what FDA-status language is accurate, what evidence exists, and what clinic-safe marketing copy looks like. Not a regulatory approval. A documented evidence record.
Device Evidence Pack — fields
Supplier Diligence Checklist
Document what you collected from the supplier before you committed.
This checklist is a documentation framework, not a supplier approval or regulatory certification. Completing it means you asked the right questions — not that the answers were independently verified.
Supplier Diligence Checklist
16 fields across 4 sections. Documentation framework, not supplier approval.
This checklist is a documentation framework, not a supplier approval or regulatory certification. Completing it means you asked the right questions — not that the answers were independently verified. Consult qualified legal, regulatory, and customs professionals before committing to any supplier or import.
This checklist is a diligence documentation aid. It does not constitute approval, certification, or regulatory clearance of any supplier, device, or claim.
Claim Cleanup Record handoff
Device Evidence Pack surfaced risky language. The Claim Cleanup Record fixes it.
A structured record showing what device claims were changed, why they were changed, what support now backs each claim, and which claims still require caution. $1,997 one-time.
Questions
What to know before submitting a device page.
Claim-reviewed device marketing. Before launch.
AuditGPT does not provide legal, medical, regulatory, FDA, import, customs, or clinical advice. It does not certify devices, suppliers, claims, imports, or compliance. It reviews public-facing claims, visible evidence, supplier-provided materials, and FDA-status language to identify proof gaps and safer marketing options.