510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163185Substantially Equivalent

OptiLux LED Illuminator

Isolux, LLC, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K163185 is the FDA 510(k) clearance record for OptiLux LED Illuminator, a class II device, cleared for Isolux, LLC on under FDA product code HBI (Illuminator, Fiberoptic, Surgical Field). FDA records list 3 510(k) clearances for Isolux, LLC, from to . As of , FDA records show no recalls naming K163185.

Clearance record

Decision date
Received
(7 days to decision)
Product code
HBI Illuminator, Fiberoptic, Surgical Field
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Isolux, LLC 1045 Collier Center Way, Naples FL
510(k) summary
Statement
Third party review
Yes

Clearances, product code HBI

Trailing 12 months

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

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