Scalp Cooling System
The Scalp Cooling System (product code PMC) is a Class 2 general and plastic surgery device intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used, regulated under 878.4360. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMC
- Device Class
- FDA class 2
- Regulation Number
- 878.4360
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252289 | Eva Scalp Cooling System | Nov 25, 2025 | Substantially Equivalent | Stemtech Medical Devices Private Limited |
| K211526 | Portable Scalp Cooling System | Oct 21, 2021 | Substantially Equivalent | Cooler Heads Care, Inc. |
| K191166 | DigniCap Delta | Jun 26, 2019 | Substantially Equivalent | Dignitana, Inc. |
| K173032 | Paxman Scalp Cooler | Jun 07, 2018 | Substantially Equivalent | Paxman Coolers Limited |
| K170871 | DigniCap Scalp Cooling System | Jul 03, 2017 | Substantially Equivalent | Dignitana AB |
| K163484 | Paxman Scalp Cooler | Apr 17, 2017 | Substantially Equivalent | Paxman Coolers Limited |
| DEN150010 | Dignitana AB DigniCap System | Dec 08, 2015 | Unknown | Dignitana AB |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.