510(k) K090754

Device
LIPOCONTROL
Applicant
OSYRIS MEDICAL
510(k) number
K090754
Product code
ORK  
Decision
Substantially Equivalent (SESE)
Decision date
2011-01-21
Date received
2009-03-20
Regulation
878.4810
Classification name
Laser Assisted Lipolysis
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BLANDINE BOUVET
Address
60 Ave. Halley F59650 Villeneuve D'Asq France FR F59650 F59650

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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