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Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Page Type
Product Code
Definition
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Physical State
The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
Technical Method
The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples.
Target Area
Area with Cellulite, Fibrous Septae, Fat, Soft Tissue.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4790
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite

§ 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]

Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

Page Type
Product Code
Definition
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Physical State
The device consists of a cutting blade powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
Technical Method
The device temporarily improves the appearance of cellulite by controlled release (cutting) of the subcutaneous tissue underneath the cellulite depressions or dimples.
Target Area
Area with Cellulite, Fibrous Septae, Fat, Soft Tissue.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4790
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4790 Powered surgical instrument for improvement in the appearance of cellulite

§ 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]