DeviceClearance

Product code OYW— General, Plastic Surgery

CELLULAZE LASER

Classification name
Laser, Cellulite Appearance
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“For the removal of fat through laser lipolysis.”

— U.S. Food and Drug Administration, device classification record for product code OYW under 21 CFR 878.4810, via openFDA

Market context for product code OYW

FDA has cleared 2 devices under product code OYW between 2012 and 2013, filed by 1 applicant company. 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 OYW

Recent clearances under product code OYW

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