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Scalp Cooling System

FDA product code PMC · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4360
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-17 – 2025-11-25

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.

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