PMC

Scalp Cooling System

Product code: PMC
Device name: Scalp Cooling System
Device class: Class 2
21 CFR: 21 CFR 878.4360
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 7

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-25.

Number	Decision date	Applicant	Device name	Summary
K252289	2025-11-25	Stemtech Medical Devices Private Limit	Eva Scalp Cooling System	PDF

1 summaries are archived here for direct download.

Official FDA classification page: PMC

Classification and pathway per current FDA publications. Data from openFDA (CC0).