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PMC — Scalp Cooling System Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K252289stemtech medical devices private limitedEva Scalp Cooling SystemNovember 25, 2025
K211526cooler heads carePortable Scalp Cooling SystemOctober 21, 2021
K191166dignitanaDigniCap DeltaJune 26, 2019
K173032paxman coolers limitedPaxman Scalp CoolerJune 7, 2018
K170871dignitanaDigniCap Scalp Cooling SystemJuly 3, 2017
K163484paxman coolers limitedPaxman Scalp CoolerApril 17, 2017
DEN150010dignitanaDignitana AB DigniCap SystemDecember 8, 2015