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Dermal Cooling Pack/Vacuum/Massager

Page Type
Product Code
Definition
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Physical State
the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Technical Method
release of fat and lipids from adipocyte cells resulting in reduction in fat layer
Target Area
areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4340
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4340 Contact cooling system for aesthetic use

§ 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]

Dermal Cooling Pack/Vacuum/Massager

Page Type
Product Code
Definition
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Physical State
the device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disrutpion or induction of adipocyte cells indicated for body contouring or reduction in circumferance of body areas.
Technical Method
release of fat and lipids from adipocyte cells resulting in reduction in fat layer
Target Area
areasof the body for which a subject wishes to have reduction in size such as abdomen, thighs, waist, hips.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4340
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4340 Contact cooling system for aesthetic use

§ 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]