510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211526Substantially Equivalent

Portable Scalp Cooling System

Cooler Heads Care, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211526 is the FDA 510(k) clearance record for Portable Scalp Cooling System, a class II device, cleared for Cooler Heads Care, Inc. on under FDA product code PMC (Scalp Cooling System). FDA's definition for product code PMC reads: "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". FDA records list one 510(k) clearance for Cooler Heads Care, Inc. As of , FDA records show no recalls naming K211526.

Clearance record

Decision date
Received
(157 days to decision)
Product code
PMC Scalp Cooling System
Regulation
21 CFR 878.4360
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cooler Heads Care, Inc. 2801 B St., #209, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PMC

Trailing 12 months
1 clearance under product code PMC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PMC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260