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Code · CFR · Title 21 — Food and Drugs · Part 878 — General and Plastic Surgery Devices · § 878.4340

§ 878.4340. Contact cooling system for aesthetic use.

87 words·~1 min read·/us/cfr/t21/s§ 878.4340·

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(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]
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§ 878.4340
Contact cooling system for aesthetic use.
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