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FDA 510(k)

Eva Scalp Cooling System

K-Number: K252289 · 2025-11-25

ApplicantStemtech Medical Devices Private Limited
Decision Date2025-11-25
Product CodePMC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Eva Scalp Cooling System is a medical device manufactured by Stemtech Medical Devices Private Limited. It received FDA 510(k) clearance on 2025-11-25 under approval number K252289. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eva Scalp Cooling System?

Eva Scalp Cooling System is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Stemtech Medical Devices Private Limited. The 510(k) number is K252289.

When was Eva Scalp Cooling System approved by the FDA?

Eva Scalp Cooling System received FDA 510(k) clearance on 2025-11-25, under approval number K252289.

What company makes Eva Scalp Cooling System?

Eva Scalp Cooling System is manufactured by Stemtech Medical Devices Private Limited.

What is the FDA product code for Eva Scalp Cooling System?

The FDA product code for Eva Scalp Cooling System is PMC.

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Related PubMed Literature

PMID: 41269388 Adverse effects of scalp cooling for the reduction of chemotherapy-induced alopecia: A systematic review and meta-analysis. Breast cancer research and treatment (2025)

Related Devices (Code: PMC)

K170871DigniCap Scalp Cooling SystemDignitana AB K163484Paxman Scalp CoolerPaxman Coolers Limited K173032Paxman Scalp CoolerPaxman Coolers Limited K191166DigniCap DeltaDignitana, Inc. K211526Portable Scalp Cooling SystemCooler Heads Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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