510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100395Substantially Equivalent

Harmony Vled Surgical Lightning System

STERIS Corporation, Mentor OH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100395 is the FDA 510(k) clearance record for HARMONY VLED SURGICAL LIGHTNING SYSTEM, a class II device, cleared for STERIS Corporation on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show one recall naming K100395.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
STERIS Corporation 5960 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FST

Trailing 12 months

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

FDA records show no clearances under product code FST in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FST, 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