Q. Can I treat my calves by using the cool smooth applicator? The area is not FDA approved. But it seems that the cool smooth applicator can be used for this area. Will the treatment be effective for calves?
A. FDA approval is provided when a manufacturer of a drug or device provides safety and efficacy for the marketing of a product.
In the case of CoolSmooth, Zeltiq, the manufacturer of the CoolSculpt device using this applicator requested its use and provided safety and efficacy data for its use on the outer thigh bulges.
Physicians trained in the use of a drug or device such as the CoolSmooth may then determine if it provides a similar standard of care using this applicator on your calves for example. This is considered a “off-label” use but acceptable if the safety and efficacious bar is met. The CoolSmooth applicator is being used “off-label” in other areas of the body such as trunk following liposuction contour deformities and inner thighs with noted improvement.
My particular concerns for CoolSmooth on the calves would include:
- Near freezing temperatures for 1-2 hours on a more distal extremity which normally will not tolerate such temperature for risk of “frostbite”.
- Poor venous return creating a clot in a vein
- Inadequate ability to target the correct tissues due to the curvature of a calf,
- And others.
I recommend you explore the use of CoolSmooth on the calves with a well experienced and CoolSculpting certified, Board Certified Plastic Surgeon.
Good luck with your decision!