Substantial equivalence
A 510(k)-cleared device received an FDA substantial-equivalence determination for its specific indications and technology. It is not an FDA certificate.
01 / EVIDENCE & SAFETY
Trust begins with the correct noun.
Concept render, physical prototype, bench test, regulatory analogue and market authorisation are different things. This site keeps them separate.
KNOWN / 已知
- Four design directions
- Concept images and interaction studies
- Open risk questions
NOT ESTABLISHED / 未确定
- Frozen intended use
- Target-market classification
- Physical performance and safety
DISPLAY CATEGORY ≠ FDA CLASSSite labels are navigation only
REGISTRATION ≠ APPROVALListing is not clearance or approval
510(k) ≠ CERTIFICATEA cleared 510(k) is product-specific
02 / FDA VOCABULARY
The pathway decides the verb.
Intended use and indications come first. They influence whether a product is a device, its classification and the route required for a named market. These notes are not a classification decision.
Premarket approval
PMA-approved is the route-specific term for applicable Class III devices. Approval must never be borrowed from another product or used as a brand badge.
New classification
A De Novo request may be granted to create a new Class I or II device type when there is no legally marketed predicate. It is neither a 510(k) clearance nor a certificate.
Administrative records
Establishment registration or device listing does not denote approval, clearance or authorisation.
No generic FDA approval
Cosmetics and their ingredients do not require FDA premarket approval, except color additives. They still must be safe for intended use and properly labeled.
FDA · Device determination ↗FDA · 510(k) ↗FDA · Approved terminology ↗FDA · Cosmetics authority ↗
03 / WHICH FRAMEWORK APPLIES
One small object, three possible rulebooks.
Which framework applies is decided by intended use, risk and the target market — not by how a product looks or where a site files it. This section explains the frameworks; it is not a classification decision for any Beauty Charms concept.
A compliance policy, not a blanket exit
CDRH guidance sets a compliance policy for low-risk products that promote a healthy lifestyle and are unrelated to diagnosing, curing, mitigating, preventing or treating a disease. It does not apply to cosmetics, drugs, foods or supplements, and the statutory carve-out it interprets is written for software functions. Whether a concept qualifies is a reviewed determination, never a self-declaration.
Exempt is not unregulated
Most Class I and some Class II device types are exempt from 510(k). Exempt devices still fall under general controls such as establishment registration, device listing, labeling, quality system requirements and adverse-event reporting.
Intended use draws the line
Under the FD&C Act, articles intended to cleanse, beautify or alter appearance are cosmetics; articles intended to diagnose, treat, mitigate or prevent disease, or to affect structure or function, are drugs or devices. One product can fall into more than one category at the same time.
Cosmetics have their own axis
The Modernization of Cosmetics Regulation Act of 2022 added obligations for cosmetic products, including facility registration, product listing, safety substantiation and adverse-event reporting. Carrier concepts on the cosmetic axis must be assessed there rather than borrowing the device vocabulary.
What the maker says it is for
Intended use is established by the objective intent of the people who market the product — labeling, advertising and overall presentation. A website's own wording is part of that record, which is why claim language is frozen before publication here.
The narrower, cleared statement
Indications for Use is the specific statement of the disease or condition a device is used for, and the target population. It appears in a cleared submission and is narrower than intended use. The two terms are not interchangeable.
FDA · General wellness policy ↗FDA · Class I & II exemptions ↗FDA · Cosmetic, drug, or both ↗FDA · MoCRA ↗
04 / CLAIM LADDER
Describe only what the evidence can carry.
The current public record supports concept and experience language only. Medical benefit claims remain empty.
Experience
Carry, open, visual intent and intended ritual.
Beauty-care intention
Must remain qualified as intended or targeted until product-specific evidence exists.
Medical
No diagnosis, treatment, cure, prevention or disease claim.
05 / TWO CLASSIFICATION LAYERS
Navigation is not regulation.
Beauty Charms display categories help users browse the site. They do not determine FDA Class I, II or III, product code, exemption or submission route.
Decorative · Makeup aid · Beauty-care · Routine · Functional-device concept
A content and browsing taxonomy. “Functional-device concept” means the regulatory pathway is undetermined, not that certification is pending.
Market + intended use + risk
Requires qualified review and evidence for the exact product. Current status: not determined.
06 / OPEN RISK FILES
Unknown means stop and test.
These are design questions, not proof of safety. Product-specific instructions can only be written after identity, output and materials are frozen.
01 / LIGHTOptical output, exposure and photosensitivity+
Wavelength, irradiance, dose, session, eye exposure and thermal rise all remain product-level questions.
02 / CURRENTElectrical output and implanted devices+
Output limits, current path, contact quality and contraindications are not yet validated.
03 / SUCTIONPressure, bruising and misuse+
Suction concepts may be stopped entirely if pressure limits, tissue risk and predictable misuse cannot be resolved.
04 / MATERIALSkin and lip contact+
Candidate silicone, plastics, metals, coatings and adhesives need product-specific contact, ageing and cleaning evaluation.
05 / HYGIENECleaning, drying and replacement+
A reusable contact part needs a verified cleaning method, dry storage and replacement interval before public instructions are final.
07 / PUBLIC EVIDENCE SUMMARY
The same six fields on every product.
Until a named reviewer and date exist, the page says so. An empty record is safer than a decorative seal.
01Intended use
Not frozen
02Target market
Not selected
03Physical state
Concept visual only
04Evidence maturity
Concept-only
05Next gate
G2 · Identity freeze
06Human review
No publication approval recorded
Products shown are early design concepts. Images and motion studies communicate intent only. They do not establish physical performance, safety, regulatory classification, clearance, approval or certification.
READ G1—G7