Definition: A Scalp Cooling System Is Intended To Reduce Or Prevent The Frequency And Severity Of Alopecia During Chemotherapy In Which Alopecia-inducing Chemotherapeutic Agents Are Used.
| Device Type ID | 5870 |
| Device Name | Scalp Cooling System |
| Physical State | A Cooling Cap Which Is Placed On The Patients Head And A Cooling System That Houses The Cooling Liquid, Controls The Temperature, And Has A User Interface |
| Technical Method | A Cooling Cap With Cooling Fluid Running Through The Cap Cools The Scalp. A Cooling Tank Consists Of A Computer Controlled System That Includes A Refrigerated Tank Containing The Cooling Agent That Maintain The Temperature Of The Cooling Fluid. |
| Target Area | The Scalp |
| Regulation Description | Scalp Cooling System To Reduce The Likelihood Of Chemotherapy-induced Alopecia. |
| 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 | 878.4360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PMC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5870 |
| Device | Scalp Cooling System |
| Product Code | PMC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Scalp Cooling System To Reduce The Likelihood Of Chemotherapy-induced Alopecia. |
| CFR Regulation Number | 878.4360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIGNITANA AB | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
PAXMAN COOLERS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |