Home / 510(k) Clearances / K252289

510(k) K252289

Eva Scalp Cooling System by Stemtech Medical Devices Private Limited — Product Code PMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2025
Date Received
July 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scalp Cooling System
Device Class
Class II
Regulation Number
878.4360
Review Panel
SU
Submission Type

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.

Other clearances for product code PMC

  • K211526 — Portable Scalp Cooling System (October 21, 2021)
  • K191166 — DigniCap Delta (June 26, 2019)
  • K173032 — Paxman Scalp Cooler (June 7, 2018)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • K163484 — Paxman Scalp Cooler (April 17, 2017)
  • DEN150010 — Dignitana AB DigniCap System (December 8, 2015)