Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130341Device Name
STRAWBERRY, STRAWBERRY & CREAM
Manufacturer
LASER LIPO LIMITED
Date Cleared
2013-09-06
(207 days)
Product Code
OLI
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
LASER LIPO LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Low level Laser model Strawberry and Strawberry and Cream can be used for the non-invasive temporary reduction in waist circumference by the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use.
Device Description
The Laser Lipo Ltd Strawberry low level laser system and Strawberry & Cream low level laser system consists of a control unit, various connection leads up to 10 paddles, 2 probes, various "Velcro" attachment straps and other accessories. A paddle is a device containing six cold red laser emitting diodes which is designed to be placed on the skin. The system can operate using 4, 6, 8 or 10 paddles that are connected to the control unit. A probe is a device containing one cold red laser emitting diode which is designed to be placed on the skin to treat specific smaller areas of fat, where a usual flat paddle won't ergonomically fit. The control unit is an electrically powered unit (100-240v, 50-60Hz auto-ranging). enabled by a main switch and key switch. Once enabled it is controlled using a button (Strawberry) or touchscreen (Strawberry and Cream) interface. The output of the diode (six per paddle) is limited to 40mW +/- 15% by a power limiting PCB from the central processing unit.
Ask a Question
Page 1 of 1