PMC — Scalp Cooling System Class II
FDA product code PMC covers "Scalp Cooling System", a Class II medical device regulated under 21 CFR 878.4360. Submissions are reviewed by the General, Plastic Surgery panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMC
- Device Class
- Class II
- Regulation Number
- 878.4360
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252289 | stemtech medical devices private limited | Eva Scalp Cooling System | November 25, 2025 |
| K211526 | cooler heads care | Portable Scalp Cooling System | October 21, 2021 |
| K191166 | dignitana | DigniCap Delta | June 26, 2019 |
| K173032 | paxman coolers limited | Paxman Scalp Cooler | June 7, 2018 |
| K170871 | dignitana | DigniCap Scalp Cooling System | July 3, 2017 |
| K163484 | paxman coolers limited | Paxman Scalp Cooler | April 17, 2017 |
| DEN150010 | dignitana | Dignitana AB DigniCap System | December 8, 2015 |