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 Cooler Heads Care, Inc. and Stemtech Medical Devices Private Limited.
FDA 510(k) Cleared Scalp Cooling System Devices (Product Code PMC)
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 Review Time
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 →