Last synced on 2 December 2022 at 11:04 pm

Skin Resurfacing Rf Applicator

Page Type
Product Code
Definition
Skin resurfacing
Physical State
Hand held device with a range of electrodes (64-144) that penetrate the top layer of the skin and then generates RF pulses to create micro-ablative points.
Technical Method
Applicator emits RF energy that flows between electrodes to create micro-ablative points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Target Area
dermatologic use
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
Not 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.

Skin Resurfacing Rf Applicator

Page Type
Product Code
Definition
Skin resurfacing
Physical State
Hand held device with a range of electrodes (64-144) that penetrate the top layer of the skin and then generates RF pulses to create micro-ablative points.
Technical Method
Applicator emits RF energy that flows between electrodes to create micro-ablative points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Target Area
dermatologic use
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
Not 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.