DeviceClearance

Product code LEJ— General, Plastic Surgery

Tanning Lamp

Classification name
Booth, Sun Tan
Device class
Class 2
Regulation
21 CFR 878.4635
Advisory panel
General, Plastic Surgery
Total cleared
81
First cleared
Most recent

Market context for product code LEJ

FDA has cleared 81 devices under product code LEJ between 1980 and 2023, filed by 63 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

last 15 years

Top applicants under product code LEJ

Recent clearances under product code LEJ

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