Last synced on 2 December 2022 at 11:04 pm

Contact Cooling For Skin Lesion Pain Relief

Page Type
Product Code
Definition
For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
Physical State
Surface contact cooling is achieved with an integrated conductive plate on skin, to lower the temperature of the skin.
Technical Method
Regulate skin temperature through surface contact.
Target Area
Body surface that needs skin lesion treatment in dermatological procedures, or temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
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
Ineligible
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]

Contact Cooling For Skin Lesion Pain Relief

Page Type
Product Code
Definition
For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
Physical State
Surface contact cooling is achieved with an integrated conductive plate on skin, to lower the temperature of the skin.
Technical Method
Regulate skin temperature through surface contact.
Target Area
Body surface that needs skin lesion treatment in dermatological procedures, or temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
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
Ineligible
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]