Definition: Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite.
| Device Type ID | 5857 |
| Device Name | Massager, Vacuum, Radio Frequency Induced Heat |
| Physical State | A Console That Generates The RF Energy. It Has Two Handpieces, An RF Handpiece To Apply Energy For The Pain Relief Indication And A Mechanical Roller Handpiece For The Cellulite Indication. |
| Technical Method | Increases The Temperature Of Skin By Deposition Of RF Waves To Relieve Minor Aches And Pain. It Uses A Mechanical Roller To Reduce The Appearance Of Cellulite. |
| Target Area | Skin. |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5857 |
| Device | Massager, Vacuum, Radio Frequency Induced Heat |
| Product Code | PBX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electrosurgical Cutting And Coagulation Device And Accessories. |
| CFR Regulation Number | 878.4400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOS S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAO GROUP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CUTERA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CYNOSURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELLMAN INT'L INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INMODE MD LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MECTRONIC MEDICALE S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VENUS CONCEPT LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VENUS CONCEPT USA INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIORA LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WINBACK USA CORP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Issue | 2 |
Human Factors Issue | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Use Of Device Problem | 2 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bios S.r.l. | II | Oct-27-2017 |