FDA Product Code PMC: Scalp Cooling System
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.
Leading manufacturers include Dignitana AB, Paxman Coolers Limited and Dignitana, Inc..
7
Total
6
Cleared
156d
Avg days
2015
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
125d
recently vs 162d historically
FDA 510(k) Cleared Scalp Cooling System Devices (Product Code PMC)
7 devices
Cleared
Nov 25, 2025
Eva Scalp Cooling System
Stemtech Medical Devices Private Limited
General & Plastic Surgery
125d
Cleared
Oct 21, 2021
Portable Scalp Cooling System
Cooler Heads Care, Inc.
General & Plastic Surgery
157d
Cleared
Jun 26, 2019
DigniCap Delta
Dignitana, Inc.
General & Plastic Surgery
56d
Cleared
Jun 07, 2018
Paxman Scalp Cooler
Paxman Coolers Limited
General & Plastic Surgery
252d
Cleared
Jul 03, 2017
DigniCap Scalp Cooling System
Dignitana AB
General & Plastic Surgery
102d
Cleared
Apr 17, 2017
Paxman Scalp Cooler
Paxman Coolers Limited
General & Plastic Surgery
126d
Not Cleared
Dec 08, 2015
Dignitana AB DigniCap System
Dignitana AB
General & Plastic Surgery
277d
About Product Code PMC - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PMC since 2015, with 6 receiving FDA clearance (average review time: 156 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PMC Product Code
Recent submissions under PMC have taken an average of 125 days to reach a decision - down from 162 days historically, suggesting improved FDA processing for this classification.
PMC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →