PMC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4360
Classification
FDA Product Code
PMC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4360
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.