510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082040Substantially Equivalent

Minisilk Ft

El.en. Electronic Engineering SpA, Calenzano, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082040 is the FDA 510(k) clearance record for MINISILK FT, a class II device, cleared for El.En Electronic Engineering Spa on under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect). FDA's definition for product code ONF reads: "A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of...". FDA records list 27 510(k) clearances for El.En Electronic Engineering Spa, from to . As of , FDA records show no recalls naming K082040.

Clearance record

Decision date
Received
(405 days to decision)
Product code
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
El.En Electronic Engineering Spa 17 Via Baldanzese, Calenzano, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONF

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