510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223440Substantially Equivalent

Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Plasma Concepts, Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223440 is the FDA 510(k) clearance record for Plasma Pen (Plasma MD); Plasma Pen (Plasma +), a class II device, cleared for Plasma Concepts on under FDA product code QVJ (Low Power Electrosurgical Devices For Skin Lesion Destruction). FDA's definition for product code QVJ reads: "For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended...". FDA records list one 510(k) clearance for Plasma Concepts. As of , FDA records show no recalls naming K223440.

Clearance record

Decision date
Received
(108 days to decision)
Product code
QVJ Low Power Electrosurgical Devices For Skin Lesion Destruction
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Plasma Concepts 800 W Cummings Park, Woburn MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVJ

Trailing 12 months

FDA records hold no clearances under product code QVJ in the trailing twelve months.

FDA records show no clearances under product code QVJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260