OYW — Laser, Cellulite Appearance Class II

FDA Device Classification

FDA product code OYW covers "Laser, Cellulite Appearance", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
OYW
Device Class
Class II
Regulation Number
878.4810
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

For the removal of fat through laser lipolysis.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123407cynosureCELLULAZE LASERMarch 29, 2013
K102541cynosureCYNOSURE CELLULAZE LASERJanuary 26, 2012