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United States
Most professional aesthetic equipment in the US market operates under FDA's General Wellness Policy — not as cleared medical devices. This page explains the FDA framework, when 510(k) clearance is genuinely required, and how to read individual product status. If a product in our range later carries FDA clearance, it will be labeled on that product page.
FDA's low-risk pathway
Premarket Notification for medical claims
Risk-based classification
Check individual product page
FDA demystified
Side by side
| Feature | 510(k) cleared device | General Wellness Policy |
|---|---|---|
| FDA pathway | Premarket Notification 510(k) | No premarket submission required |
| Required claims review | Yes — substantial equivalence demonstration | No — no medical claims permitted |
| Time to clear | 3–9 months FDA review | Immediate (manufacturer self-determination) |
| Cost | $15,000–100,000+ submission and consulting | Manufacturing compliance only |
| Permitted marketing | Cleared indications + general wellness | General wellness, no disease claims |
| Risk profile | Medical-grade device | Low-risk consumer product |
| Our current range | Not applicable (no products cleared) | ✓ Where our range operates |
Do you need 510(k)?
Will you market the equipment as treating a specific medical condition?
Will you make any therapeutic or diagnostic claims?
Will the device be operated by physicians for medical purposes?
Will you use the device for cosmetic enhancement only (no medical claims)?
Will the device be sold to the general public for personal cosmetic use?
Will salon operators use it for cosmetic services without medical claims?
Have you verified your declared use with FDA guidance for your product category?
Deep dive
FDA's 2019 guidance on "General Wellness: Policy for Low Risk Devices" establishes that low-risk products promoting healthy lifestyle (sleep, fitness, stress management, cosmetic appearance, weight management for general wellness) fall outside FDA medical-device regulation. The policy explicitly mentions cosmetic appearance enhancement. Our current product range operates under this policy.
510(k) clearance is needed when the device makes medical claims, intends to diagnose or treat a condition, or falls into specific predicate device categories that FDA has determined require clearance. Examples: IPL devices marketed for "removal of unwanted hair" (typically 510(k) needed) vs. "cosmetic hair reduction" (General Wellness applies). The wording matters legally.
A manufacturer can have some products in General Wellness category and other products with 510(k) clearance. The classification is per-product (more precisely, per-product-per-indication), not per-company. Always check the specific product detail page for the latest clearance status.
FDA pathways explained
For low-risk products promoting general wellness. No premarket FDA submission required. Cosmetic enhancement, weight management for general wellness, sleep, fitness, stress all qualify. No specific disease claims permitted. Our current product range operates here. Fastest path to market — defined by manufacturer self-classification with FDA guidance support.
Common misunderstandings
Wrong. Registration is administrative. Approval / clearance requires submission and review. "Registered" alone is the weakest FDA statement.
Wrong. General Wellness category is FDA-recognized and intentional. Most aesthetic equipment globally operates outside medical-device FDA scope.
Wrong. FDA regulates US market entry. EU, Canada, Australia etc. have their own regulators. "FDA cleared" is meaningless outside US.
Misleading. Cleared devices remain on market unless FDA recalls or revokes. Major device modifications trigger re-clearance.
FDA FAQ
Possibly, for specific products where the market opportunity justifies the cost. If we do, the cleared product will be explicitly labeled with its 510(k) K-number on the product detail page. Our current product range default is General Wellness Policy / cosmetic equipment.
We provide all standard documentation for US customs entry of cosmetic equipment. If a future product receives 510(k) clearance, the supporting documentation will be available on that product page.