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510(k) K163484

Paxman Scalp Cooler by Paxman Coolers Limited — Product Code PMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2017
Date Received
December 12, 2016
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

  • K173032 — Paxman Scalp Cooler (June 7, 2018)

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)
  • K173032 — Paxman Scalp Cooler (June 7, 2018)
  • K170871 — DigniCap Scalp Cooling System (July 3, 2017)
  • DEN150010 — Dignitana AB DigniCap System (December 8, 2015)