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Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Page Type
Product Code
Definition
An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
Physical State
Radiofrequency current generator and electrode applicators
Technical Method
Radiofrequency electrical current (i.e., electrosurgical device)
Target Area
skin wrinkles and rhytides
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4420
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4420 Electrosurgical device for over-the-counter aesthetic use

§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.

(a) Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.

(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.

(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.

(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Instructions for cleaning the device must be validated.

(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.

(8) Software verification, validation, and hazard analysis must be performed.

(9) Labeling must include:

(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.

(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.

(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.

[81 FR 42244, June 29, 2016]

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Page Type
Product Code
Definition
An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
Physical State
Radiofrequency current generator and electrode applicators
Technical Method
Radiofrequency electrical current (i.e., electrosurgical device)
Target Area
skin wrinkles and rhytides
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4420
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4420 Electrosurgical device for over-the-counter aesthetic use

§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.

(a) Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.

(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.

(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.

(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Instructions for cleaning the device must be validated.

(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.

(8) Software verification, validation, and hazard analysis must be performed.

(9) Labeling must include:

(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.

(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.

(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.

[81 FR 42244, June 29, 2016]