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Start with five separate records

Use one procurement file for the proposed configuration, with five sections: identity and instructions; regulatory status; output and supporting evidence; training; maintenance and repairs. Ask the supplier to answer by question number and identify the document and page supporting each answer.

Track each answer with one of four statuses:

• Requested: you are waiting for the reply or document.
• Received but unverified: the material has arrived, but you have not checked it.
• Verified within stated scope: the issuer, device match and scope have been checked; record what that check covers.
• Unresolved: a gap or conflict still needs an answer.

Receiving a document is not the same as verifying it.

Questions to send a cavitation machine supplier

1. Who made this exact configuration?

“Please identify the legal manufacturer, supplier, model and configuration being offered. Send photographs of the device identification and rating labels, the accessory list with part identifiers, and the applicable software version.”

Keep the quotation, label photographs and manual together. If the sales name differs from the manufacturer's model name, request a written explanation linking them. Similar cabinets and matching connectors are not an adequate identity trail.

2. Can we review the current instructions before purchase?

“Please provide the complete instructions for use (IFU), including revision and model applicability, in a language our operators can read. Identify the intended operator, intended use, permitted treatment sites, exclusions, warnings, fault handling and cleaning instructions.”

Ask which instructions cover each attachment and whether a software or accessory change requires different documentation. Videos should supplement the matching IFU. A supplier resource library reviewed for this guide groups documents by series and device; that organization illustrates the need to select the right document, without proving its contents or any machine's performance. [4]

3. What supports the regulatory claim in our market?

“State the destination market and the exact regulatory claim. Provide the official record or applicable conformity documents, with device identity, issuer, reference number and scope. Explain any difference between the document name and the offered model.”

For US claims, FDA establishment registration and device listing do not mean approval, clearance or authorization. FDA does not issue device registration certificates. Verify a claimed authorization through the relevant official record rather than relying on a certificate image. [1]

For example, FDA record K100874 identifies LipoSonix System Model 1, a high-intensity focused ultrasound system indicated for non-invasive waist circumference reduction. Its summary describes a thermal tissue effect. It does not clear an unidentified low-frequency cavitation system. [2] US records also do not settle EU, UK or Australian market status. Have unresolved jurisdiction-specific claims checked through the relevant authority or a qualified regulatory adviser.

4. Which output has actually been measured?

“Provide the output specification for the ultrasound applicator and explain the units. Which report supports it, which configuration was tested, and under what conditions? Who performed the measurements, when, and against what acceptance criteria?”

Ask the supplier to distinguish electrical input from emitted acoustic output, and nominal settings from measured values. Request the measurement method, equipment calibration information, report identifier, results and limits of applicability. An engineer can assess whether the method and report are appropriate for the system.

FDA's guidance for focused ultrasound systems for aesthetic use discusses acoustic power measurements, beam characterization and system performance testing. This is a focused-device reference showing what documented characterization looks like; it is not a universal acceptance standard for non-focused salon machines. [3]

Do not substitute a water demonstration, audible tone or handpiece warmth for a documented measurement report. Do not improvise an output test on a client.

5. Does the supporting evidence match our proposed service?

“For each outcome claim, identify the original study and the tested device, applicator, technology and intended use. Explain how those match this configuration, and disclose the remaining differences.”

Keep low-frequency non-focused ultrasound, focused mechanical ultrasound, thermal high-intensity focused ultrasound (HIFU), and 1 MHz systems separate. Radiofrequency (RF), vacuum and other attachments need their own evidence trail. A combined console does not establish that one component's evidence covers every function. Do not accept the LipoSonix record as a shortcut around this matching task. [2]

6. What does training include—and how is competence checked?

“Who delivers training, which exact configuration does it cover, and what is the syllabus? How are screening, IFU use, modality identification, cleaning, record keeping, stop criteria and escalation assessed? Is there supervised practice, a competence check and a route for later questions?”

Request the syllabus and assessment approach in writing. Clarify what an attendance certificate certifies. Keep the training record separate from verification of the operator's local professional scope, premises requirements and insurance conditions; request confirmation from the relevant bodies rather than treating supplier training as the answer.

7. Who maintains, repairs and releases the machine back to service?

“Provide the maintenance requirements, approved replacement parts, cleaning compatibility information, warranty exclusions and service contact. Which checks can operators perform, and which require qualified service personnel?”

Ask where repairs take place, how faults are triaged, who handles transport, how parts availability is communicated, and what records accompany a repair. Request the manufacturer's return-to-service checks, including any applicable output verification. Record a promised response time separately from a repair turnaround; neither should be assumed from the phrase “lifetime support.”

8. What happens if the delivered unit does not match?

“Can the supplied model, accessories, labels, manual and agreed documents be reconciled at delivery? What is the written process for a mismatch, missing documentation, damage or a failed manufacturer-supported acceptance check?”

Agree on the acceptance process before delivery. Separate an external condition and inventory check from technical commissioning. Have qualified personnel plan technical checks using manufacturer-supported methods. A powered screen is not the completion of equipment acceptance.

Document and verify each answer

Create one entry per question. Preserve the original reply and attachment, then add your own verification notes. Use these fields:

• Question and scope: what you asked; model, configuration, market and proposed use.
• Supplier response: exact reply, respondent's role and date.
• Evidence: file name, issuer, reference number, revision and relevant page.
• Verification: what was independently checked, by whom and when.
• Limit or conflict: what the document does not cover, or which identities disagree.
• Decision: status, outstanding action, owner and agreed review date.

If a report is confidential, ask whether your qualified reviewer can inspect it under an appropriate arrangement. Record what was actually reviewed. An inaccessible report remains unverified for your review; confidentiality does not establish that its conclusions are valid or invalid.

Close a question only within its verified scope. “Manufacturer identity confirmed” does not also mean “clinical effects confirmed.” Save later corrections as new versions so the reason for a decision remains visible.

Common mistakes that hide missing evidence

• Accepting “professional grade” as a document. Ask for a defined claim and its supporting record.
• Saving only a screenshot of a certificate. Keep the complete document and verify its issuer and scope.
• Combining all approvals into one checkbox. Device status, output evidence, operator authority and support commitments answer different questions.
• Accepting “same factory” as a model match. Resolve changes in identity, software and accessories in writing.
• Treating the sales conversation as the service agreement. Preserve the written terms and responsible party.

Frequently asked questions

What if the supplier changes the model after answering?

Reopen every answer affected by the change. Compare identity, IFU, accessories, output reports and regulatory scope again, and retain the superseded documents. A previous review should not silently follow a replacement model.

Must a supplier disclose every confidential technical detail?

This checklist is a review framework, not a legal disclosure rule. Ask for enough traceable information for the relevant reviewer to assess the claim. If access is restricted, record the restriction and what remains unresolved.

Can a remote demonstration replace document review?

Use it to clarify controls, attachment identity and support arrangements. Keep its date and configuration in the file. It does not replace the matching IFU, an official regulatory record or documented output testing.

The useful outcome is a traceable decision

Before committing to purchase, make sure each important answer has a supporting document or a clearly recorded gap. At delivery, check that the equipment matches the documents you reviewed. Keep unresolved safety or identity questions open until the appropriate reviewer resolves them.