Device user rating

FDA verification

510(k) citations are verified against the FDA clearance and PMA databases: 382 of 485 devices currently carry a verified citation, and the rest are working through our audit queue. Where a clearance is evidenced, we record the clearance number and publish it on the device profile alongside the plain-English indication the device was cleared for — not the marketing claim. Where no US clearance exists, we say so explicitly rather than leaving the field blank.

Devices show one of these states: FDA Cleared — a clearance we have evidenced with a 510(k) number; Registered — no device clearance identified; General wellness product — not reviewed by FDA; and No US 510(k) located. We only publish "FDA Cleared" with a clearance number and a link to the public FDA record; a clearance we cannot evidence stays in our internal audit queue rather than on the profile. "Cleared" is not "approved" — see our FDA guide. Each profile also carries a "Last verified" date so you can see how fresh the check is.

How profiles are produced

Device profiles are drafted with automated research assistance, then verified against primary sources — the FDA 510(k) database, manufacturer documentation and operator websites — and reviewed by a person before publication. Automated checks re-validate FDA citations on an ongoing basis and flag any record whose clearance evidence no longer holds; flagged records move back into the audit queue and the citation stops displaying until it is confirmed again. Where a fact cannot be traced to a primary source, the field is left empty rather than estimated.

Chain data confidence

Chain fleet pairings on the Chains pages carry a confidence level, because equipment lists are rarely published in full:

Confirmed

The chain names the device in its own materials — service menu, press release, franchise disclosure document or a manufacturer partnership announcement.

Reported

Multiple credible secondary sources — trade press, operator interviews or location staff — place the device in the fleet, but the chain has not published it centrally.

Inferred

The chain advertises a branded treatment that only this platform delivers, so the device is almost certainly present. Treat it as a strong signal, not a fact.

The verification badges

A Verified Manufacturer has claimed and confirmed their profile. Every owner and operator review publishes in one of two tiers: “Verified owner”, when we have accepted documentary proof of ownership — an invoice, serial-plate photo, financing statement or service record — and “Attested”, when the reviewer signed a legal certification instead, which is what former owners who no longer hold the paperwork use. The Verified tier is proof of ownership, so it stays with owners; every badge also names the reviewer's role, so an operator's review publishes as “Attested operator”. Both tiers require a signed certification and a recorded signal that the reviewer is a real person, both publish only after a person approves them, and both count toward the Device user rating; we never publish a review labeled unverified. Badges are not endorsements, ratings, or paid placements, and are not for sale.

Review moderation

Every submitted review is screened by a human before it appears. We check for manufacturer-planted content, competitor attacks, and claims that identify patients. The two publication tiers are explained under the verification badges above.

We never edit the substance of a review. We will remove personally identifying details or decline to publish, but we do not soften criticism, and manufacturers cannot have negative reviews removed. Full detail is in our review policy.

Consumables and operating economics

Consumable, lock-in and per-treatment figures come from dealer parts catalogs, manufacturer stores, FDA summaries and named trade-press interviews. AI-aggregator sites are excluded. Where a per-treatment figure is arithmetic from two published numbers on the same page, we label it derived. Currencies are published as found and never converted, and we state a gap rather than estimate a number.

Annual service contracts are the worst-documented field in this industry: none of Candela, Cynosure, Solta, InMode, BTL, Cutera or Sciton publishes a service price. Where we show a service figure it comes from a dealer or distributor, not the manufacturer. Where we show nothing, nothing has been published.

What we publish about legal and safety matters

We publish a legal or safety matter on a public page only when all five of these are true:

1. A regulator or a court has taken a final, documented action — a recall, a warning letter, a safety communication, a judgment or a consent order. Filed complaints, allegations and a company’s own account of its lawsuits are none of these.
2. The action is on a primary public record we can link to, so you can read the original rather than our summary.
3. The action names the device or the company on the page — not a sibling product, a former owner or a similarly named business.
4. It changes something a buyer can act on: the FDA record, the safety of a unit in service, or whether parts, consumables or service remain available.
5. We can state it in the regulator’s or court’s own terms, with dates, and without characterising fault beyond that record.

Anything that fails any one of those five stays off the public pages, whichever company it concerns, and that includes the two brands the founder’s company distributes. We removed the trademark, manufacturing-lineage and litigation narratives we previously carried, because they were allegations rather than findings. Every manufacturer named in a safety action gets a right of reply through /claim, published alongside the record, and corrections go through the same channel as all our data.

On timing: a verified regulatory or safety record — a recall, a warning letter, a safety communication — publishes as soon as we have checked it against the primary record, with a reply link for the company on the same page. Ordinary factual updates, such as a price range, a consumable figure or a warranty term, may be sent to a claimed company for clarification first, but no update is ever held for a company’s approval, and no company sees a page before it publishes.

What manufacturers can pay for

• Labeled placement. Sponsored slots in category listings and on relevant pages. Every one carries a visible "Sponsored" label and is excluded from ranking logic.
• Premium profiles. A claimed profile with brand assets, spec sheets, financing details and a direct contact route for buyers. The editorial sections of that profile stay ours.
• Qualified buyer introductions. When an operator asks to be connected to a vendor, we pass that request along. Operators always opt in.

Pricing and tiers are on the for manufacturers page.

What manufacturers cannot pay for

• A higher position in any ranking, comparison table or category listing.
• Removal, suppression or softening of a negative owner review.
• Changes to FDA status, clearance numbers or indication language.
• Changes to our pricing ranges, consumable cost estimates or resale assessments.
• The Device user rating, or any text on a device record.

A paying manufacturer and a non-paying manufacturer are treated identically by our data pipeline.

How the payback calculator works

Estimate how long it could take to recover the purchase price from your treatment revenue after the costs you enter. This is a planning model, not a forecast or guarantee.

The calculation

• Per-treatment contribution = treatment price minus supplies and labor.
• Monthly contribution = per-treatment contribution × treatments per month, minus your monthly service reserve.
• Payback months = purchase price ÷ monthly contribution. A zero or negative contribution cannot recover the purchase price.

Where starting values come from

• Equipment price: the displayed range midpoint or a labeled configuration price.
• Treatment price: a recorded price with source information, or a median from at least three eligible published reviewer price reports.
• Planning examples: some devices offer separately labeled distributor estimates. These are editable examples, not verified owner averages or recommended fees.
• Supply costs: a sourced per-treatment figure, a labeled planning estimate, or your own allowance. Missing data never means $0. Enter zero only when you have confirmed it applies.

Before you rely on the result

• Review every starting value. Default treatment volume is illustrative; the low and high scenarios vary your volume by 25%.
• Blank labor and service fields count as zero in the calculation and can make payback look faster. Contribution figures stay hidden until you edit labor or enter a positive service reserve.
• Financing, marketing, taxes and other overhead are excluded. Account for these separately when budgeting.

How we decide a device is “FDA-cleared for” a goal

A device is only tagged as cleared for a goal when FDA’s own verbatim indications text for a cited record contains one of the phrases below and that phrase is not sitting only inside an excluded phrase. Where we hold no verbatim text, no goal tag is printed at all — the card states the FDA status and links the record instead. Generic surgical wording (“incision”, “excision”, “ablation, vaporization”, “coagulation of soft tissue”, “coagulation and hemostasis”, “electrocoagulation and hemostasis”, “dermatologic and general surgical procedures”) never satisfies a goal on its own.

Corrections

We publish material corrections in the device history timeline on each profile, with a date and a reason. If you believe something on this site is wrong, tell us and we will check it against source documents.