Last synced on 2 December 2022 at 11:04 pm

Electrosurgical Coagulation For Aesthetic

Page Type
Product Code
Definition
For the treatment of spider vein or telangiectasia by thermocoagulation.
Physical State
Electrosurgical generator and needle electrodes
Technical Method
High Frequency radio wave energy
Target Area
small surface blood vessels
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

Electrosurgical Coagulation For Aesthetic

Page Type
Product Code
Definition
For the treatment of spider vein or telangiectasia by thermocoagulation.
Physical State
Electrosurgical generator and needle electrodes
Technical Method
High Frequency radio wave energy
Target Area
small surface blood vessels
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4400
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4400 Electrosurgical cutting and coagulation device and accessories

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.