(21 days)
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No
The description focuses on the physical mechanisms of action (heat, light, RF, massage, vacuum) and does not mention any computational or algorithmic components related to AI/ML. The performance studies described are related to hardware modifications, not software or algorithmic performance.
Yes
The device is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences, which are all therapeutic benefits.
No
The device description and intended use do not mention any diagnostic capabilities. The VelaShape system is indicated for therapeutic purposes like pain relief, circulation improvement, and appearance reduction, not for diagnosing conditions.
No
The device description and performance studies clearly indicate the device is a hardware system utilizing light energy, RF energy, massage, and vacuum, not solely software.
Based on the provided information, the VelaShape device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (relief of muscle aches/pain, muscle spasm, improved blood circulation, cellulite reduction, thigh circumference reduction) are all related to treating or affecting the body directly. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device description details a system that applies heat and mechanical manipulation to the tissue. This is a therapeutic or aesthetic treatment, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
Therefore, the VelaShape device, as described, falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
Product codes
MUV
Device Description
The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Minor hardware modifications were performed to support the change of the VelaShape system infrared (IR) light source. Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications. Electromagnetic compatibility or electrical safety testing was not required to support this modification. Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
i