Product code ORK— General, Plastic Surgery

LIPOCONTROL

Classification name: Laser Assisted Lipolysis
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2011-01-21
Most recent: 2011-01-21

FDA classification definition

“Intended to be used for laser assisted lipolysis”
— U.S. Food and Drug Administration, device classification record for product code ORK under 21 CFR 878.4810, via openFDA

Market context for product code ORK

FDA has cleared 1 device under product code ORK, all in 2011, 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.

Top applicants under product code ORK

Osyris Medical1 clearance

Recent clearances under product code ORK

K090754 — LIPOCONTROLOsyris Medical·2011-01-21

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