510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001223Substantially Equivalent

Aculux, Model Ax3001, Ax3002

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

K001223 is the FDA 510(k) clearance record for ACULUX, MODEL AX3001, AX3002, a class II device, cleared for Aculux on under FDA product code FQP (Lamp, Operating-Room). FDA records list 2 510(k) clearances for Aculux, from to . As of , FDA records show no recalls naming K001223.

Clearance record

Decision date
Received
(67 days to decision)
Product code
FQP Lamp, Operating-Room
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aculux 273 S. Airport Pulling Rd., Naples FL
510(k) summary
Statement
Third party review
No

Clearances, product code FQP

Trailing 12 months

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

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