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The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

• lift the eyebrow .
• lift lax submental (beneath the chin) and neck tissue .

The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

• . ensure proper coupling of the transducer to the skin
• confirm appropriate depth of treatment such as to avoid bone .

The Ulthera System consists of the following components:

• . Ulthera Control Unit
• Handpiece .
• Transducers .

The provided text describes an FDA 510(k) summary for the Ulthera® System. However, it explicitly states:

"No new performance testing was performed to support the new Performance Data: indications. There have been no changes to previously cleared device (K121700, Ulthera® System) that would result in a new 510(k). Imaging capabilities of the Ulthera® System have been included in the device's profile since the original clearance. Clinical literature and ultrasound images were provided."
"There have been no changes to previously cleared Ulthera® System Conclusion: (K121700) that would result in a new 510(k)."

This means that this specific submission (K132028) did not conduct a new study to prove acceptance criteria because it's a re-submission for minor changes or clarifications, not new performance claims. The device relies on its previous clearances (K121700 and K072505 for the Ulthera System, and K983945 for the predicate device DermaScan C) for performance data.

Therefore, a detailed table of acceptance criteria and reported device performance from this specific document against a new study is not available. The document asserts substantial equivalence to predicate devices based on design, materials, principle of operation, and intended use, and provides no new performance data or study details for the current submission.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not present new acceptance criteria or reported device performance data from a new study. It relies on the performance proven for the predicate devices and prior clearances of the Ulthera System.

2. Sample Size and Data Provenance for Test Set: Not applicable for this submission as no new performance testing was conducted.

3. Number and Qualifications of Experts for Ground Truth: Not applicable for this submission as no new performance testing was conducted.

4. Adjudication Method for Test Set: Not applicable for this submission as no new performance testing was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for this submission. The document doesn't mention any MRMC study.

6. Standalone Performance Study: Not applicable for this submission as no new performance testing was conducted.

7. Type of Ground Truth Used: Not applicable for this submission as no new performance testing was conducted.

8. Sample Size for Training Set: Not applicable for this submission as no new machine learning algorithm development requiring a training set is described.

9. How Ground Truth for Training Set Was Established: Not applicable for this submission.

Conclusion from the document:
The Ulthera System's imaging subsystem is considered equivalent to the predicate device, DermaScan C (K983945), in terms of "patient contact material biocompatibility, electromagnetic compatibility, and medical electrical safety standards" as well as "general specifications, device settings and intended use." This equivalence forms the basis of its clearance for the stated indications without the need for new performance studies in this specific 510(k) submission.

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