Definition: The Device Is A Combination Of A Cooling Pad Associated With A Vacuum Or Mechanical Massager Intended For The Disrutpion Or Induction Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumferance Of Body Areas.
| Device Type ID | 5820 |
| Device Name | Dermal Cooling Pack/vacuum/massager |
| Physical State | The Device Is A Combination Of A Cooling Pad Associated With A Vacuum Or Mechanical Massager Intended For The Disrutpion Or Induction Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumferance Of Body Areas. |
| Technical Method | Release Of Fat And Lipids From Adipocyte Cells Resulting In Reduction In Fat Layer |
| Target Area | Areasof The Body For Which A Subject Wishes To Have Reduction In Size Such As Abdomen, Thighs, Waist, Hips. |
| Regulation Description | Contact Cooling System For Aesthetic Use. |
| 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 | 878.4340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5820 |
| Device | Dermal Cooling Pack/vacuum/massager |
| Product Code | OOK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Contact Cooling System For Aesthetic Use. |
| CFR Regulation Number | 878.4340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ZELTIQ AESTHETICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZELTIQ AESTHETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
| Device Problems | |
|---|---|
Insufficient Information | 14 |
Applicator | 13 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Use Of Device Problem | 2 |
Off-Label Use | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 43 |