Product code FQP— General, Plastic Surgery

ACULUX, MODEL AX3001, AX3002

Classification name
Lamp, Operating-Room
Device class
Class 2
Regulation
21 CFR 878.4580
Advisory panel
General, Plastic Surgery
Total cleared
5
First cleared
Most recent

Market context for product code FQP

FDA has cleared 5 devices under product code FQP between 1977 and 2000, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code FQP

Recent clearances under product code FQP

Data sourced from openFDA. This site is unofficial and independent of the FDA.