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U.S. Department of Health and Human Services

Product Classification

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Device scalp cooling system
Regulation Description Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
Definition 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.
Physical State a cooling cap which is placed on the patients head and a cooling system that houses the cooling liquid, controls the temperature, and has a user interface
Technical Method A cooling cap with cooling fluid running through the cap cools the scalp. A cooling tank consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that maintain the temperature of the cooling fluid.
Target Area The scalp
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePMC
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4360
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible