LogoFDA 510(k) Search
K Number
K122389
Device Name
TRUSCULPT
Manufacturer
CUTERA, INC.
Date Cleared
2012-11-02

(87 days)

Product Code
PBX
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The truSculpt infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the truSculpt device is substantially equivalent to legally marketed predicate devices.

The letter mentions:

  • Device Name: truSculpt
  • Regulation Number: 21 CFR 878.4400 (Electrosurgical cutting and coagulation device and accessories)
  • Indications For Use:
    • Topical heating for elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
    • Temporary reduction in the appearance of cellulite (when used as a massage device).

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for any tests.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies or effect sizes.
  6. Results from standalone (algorithm only) performance studies.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

To obtain this information, you would typically need to refer to the 510(k) submission summary or the actual study reports that were submitted to the FDA as part of the clearance process, which are not included in this document.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.