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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 878 - General and Plastic Surgery Devices |
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Subpart E - Surgical Devices |
§ 878.4340 - Contact cooling system for aesthetic use.
Latest version.
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§ 878.4340 Contact cooling system for aesthetic use.
(a) Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.
(b) Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
[76 FR 6553, Feb. 7, 2011]