510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240297Substantially Equivalent

Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

US Medical Innovations, LLC, Tacoma Park MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240297 is the FDA 510(k) clearance record for Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS), a class II device, cleared for Us Medical Innovations, LLC on under FDA product code OAB (Low Energy Direct Current Thermal Ablation System). FDA's definition for product code OAB reads: "Ablation of soft tissue". FDA records list 5 510(k) clearances for Us Medical Innovations, LLC, from to . As of , FDA records show no recalls naming K240297.

Clearance record

Decision date
Received
(92 days to decision)
Product code
OAB Low Energy Direct Current Thermal Ablation System
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Us Medical Innovations, LLC 6930 Carroll Ave., Tacoma Park MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAB

Trailing 12 months
3 clearances under product code OAB in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260