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510(k) K173032

Paxman Scalp Cooler by Paxman Coolers Limited — Product Code PMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2018
Date Received
September 28, 2017
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 by Paxman Coolers Limited

  • K163484 — Paxman Scalp Cooler (April 17, 2017)

Other clearances for product code PMC

  • K252289 — Eva Scalp Cooling System (November 25, 2025)
  • K211526 — Portable Scalp Cooling System (October 21, 2021)
  • K191166 — DigniCap Delta (June 26, 2019)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • K163484 — Paxman Scalp Cooler (April 17, 2017)
  • DEN150010 — Dignitana AB DigniCap System (December 8, 2015)