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 the device name listed in this FDA 510(k) record. The listed applicant is Stemtech Medical Devices Private Limited. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Stemtech Medical Devices Private Limited. The 510(k) number is K252289.

When did Eva Scalp Cooling System receive FDA 510(k) clearance?

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

Who is the listed applicant for Eva Scalp Cooling System?

The FDA 510(k) record lists Stemtech Medical Devices Private Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: PMC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

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