冷冻溶脂 - cryolipolysis - FDA 510k - 认证

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E - Surgical Devices

Sec. 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.
(a) Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.

(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.

(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.

(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.

(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.

[79 FR 31861, June 3, 2014]

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