FDA Approved and Cleared Medical Lasers
The two basic types of FDA approved items are one of two categories: Approved or Cleared. The FDA will assign a “510K” number when the device is ready for market and has been thoroughly tested. A Medical Director is required on board in all US states.
1) Approved Medical Devices-FDA approval is necessary to make sure patients using certain medical devices will be safe while utilizing the product. Devices go through rigorous study and examination before being allowed to be approved into the health care market. It also needs to be proven that the medical device will not only not do harm, but also that it will do good. The entire purpose of a medical device is to improve someone’s health, and if the item does not pass that inspection, it will not receive Approval or Clearance by the FDA.
2) Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. FDA Clearance is equal for usage in the medical field to FDA Approved. These devices are able to be marketed in used in the USA with proper training and certification.
1) Strawberry Laser Lipo Inch Loss Unit
FDA Cleared: YES, 2013
FDA 510K- #130341, Class II medical device
Clinical Trial: YES, excellent results, 3.74 inch loss after eight treatments in study
Technology: Laser Diode, 650nm, lipolysis by release of fat cell contents into the body and flushed out over the nex 12-24 hours
Results: 2-3 inch reduction on your first visit
Class II Medical Device: Requires a Medical Director (MD or DO) on board
2) The Lean Machine
FDA Cleared: NO
Made in China, Illegal to ship in or use in the USA
Not Approved or Cleared by the FDA, BEWARE!
3) Sculpsure ™
FDA Cleared: YES, 2015
FDA 510K- #K150230, Class II medical device
Technology: Laser Diode, 1086nm, lipolysis by destruction of fat cells with heat
Results: Vary. Takes 8-10 week to determine each individual’s loss.
Class II Medical Device: Requires a Medical Director (MD or DO) on board
4) Coolscupting ™ Cyrofreeze Laser
FDA Cleared: YES
FDA 510K- #151179, Class II medical device
Technology: Cryofreezing of fat cell causing destruction of cell, Low BMI required, Results Vary
Class II Medical Device: Requires a Medical Director (MD or DO) on board