Product code PMC— General, Plastic Surgery

“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.”

FDA has cleared 7 devices under product code PMC between 2015 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20211 clearance
• 20191 clearance
• 20181 clearance
• 20172 clearances
• 20151 clearance

• Paxman Coolers Limited2 clearances
• Dignitana AB2 clearances
• Stemtech Medical Devices Private Limited1 clearance
• Dignitana, Inc.1 clearance
• Cooler Heads Care, Inc.1 clearance

• K252289 — Eva Scalp Cooling SystemStemtech Medical Devices Private Limited·2025-11-25
• K211526 — Portable Scalp Cooling SystemCooler Heads Care, Inc.·2021-10-21
• K191166 — DigniCap DeltaDignitana, Inc.·2019-06-26
• K173032 — Paxman Scalp CoolerPaxman Coolers Limited·2018-06-07
• K170871 — DigniCap Scalp Cooling SystemDignitana AB·2017-07-03
• K163484 — Paxman Scalp CoolerPaxman Coolers Limited·2017-04-17
• DEN150010 — Dignitana AB DigniCap SystemDignitana AB·2015-12-08