510(k) K252289
K252289 is an FDA 510(k) premarket notification submitted by Stemtech Medical Devices Private Limited for the device "Eva Scalp Cooling System". The FDA issued a decision of Substantially Equivalent on November 25, 2025. The device falls under product code PMC (Scalp Cooling System), a Class II device regulated under 21 CFR 878.4360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2025
- Date Received
- July 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scalp Cooling System
- Device Class
- Class II
- Regulation Number
- 878.4360
- Review Panel
- SU
- Submission Type
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.