K211526 is an FDA 510(k) clearance for the Portable Scalp Cooling System. This device is classified as a Scalp Cooling System (Class II - Special Controls, product code PMC).
Submitted by Cooler Heads Care, Inc. (San Diego, US). The FDA issued a Cleared decision on October 21, 2021, 157 days after receiving the submission on May 17, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4360. 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..
| 510(k) Number | K211526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2021 |
| Decision Date | October 21, 2021 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PMC - Scalp Cooling System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4360 |
| 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. |