FDA Has Approved Zeltiq Device for Several Uses
Zeltiq device approved by FDA for Several Uses
New York City, NY–The FDA has approved the Zeltiq in 510(K) application K090094. Following is a quote from the official FDA document which describes the use for which the device was approved:
“INDICATION FOR USE: The Zeltiq System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.”
Dr. Sydney Coleman was the lead author in a paper on the device. The study demonstrated that cryolipolysis treatment can cause substantial reductions in subcutaneous fat volume and changes in the contour of the treated love handle without damage to the skin or underlying tissues. The Zeltiq device has not been approved by the FDA for the purposes discussed in the paper.
A preview of the article can be viewed as a pdf from APS. Or the article can be seen in full by accessing the Journal of Aesthetic Plastic Surgery.
For a review of the paper check out Aesthetic Device Review.
For background on Zeltiq and Cryolipolysis, please refer to previous postings entitled Freezing Fat for Natural Body Sculpting and Noninvasive Liposuction Alternative.
Dr. Sydney Coleman received an updated, advanced version of the Zeltiq Device and has been using this version for several months. Click here to read more.
Please call 212 571 5200 for more information.
© Coleman 2009
For FDA Status Update click here.
Dr. Sydney Coleman of New York City combines the BRAVA system with Breast LipoStructure
Dr. Sydney Coleman presented his experience with using the BRAVA system before and after fat grafting to the breast at three conferences in the last week:
Dr. Coleman showed examples of breast augmentation and reconstruction using autologous fat combined with the BRAVA system. He felt that the BRAVA system of reverse tissue expansion has been improving the excellent results he has already been obtaining with fat grafting to the breast.
Before (left) and after (right) Dr. Sydney Coleman placed about 200 ml of fat into each breast
Breast Augmentation with only one session of Structural Fat Grafting
The patient in these photos presented for an enhancement in the shape of her breast, and an improvement in the size of her lower breasts. Before and after about 200 ml of refined fat into each breast. She wore the BRAVA before the procedure, but not afterward.
Patient’s primary goal was increasing the size of her lower breasts
For more detailed information about fat grafting to the breast, please refer to LipoStructure.com.
For information on the consultation, procedure and pricing for Dr. Coleman’s fat grafting to the breast CLICK HERE.
Check out these links more information on fat grafting to the breasts:
Dr. Sydney Coleman demonstrates Breast Reconstruction with LipoStructure on The Doctors
Coleman lectures on fat grafting for breast reconstruction at the American College of Surgeons
Lipofilling: a role in breast reconstruction surgery From “Behind the Medical Headlines” produced by the Royal College of Physicians of Edinburgh and Royal College of Physicians and Surgeons of Glasgow
Breast Augmentation Via Fat Grafting From “Plastic Surgery Practice”
Breast Implant Problems Solved with Coleman Fat Grafting
Fat Grafting to the Breast Revisited: Safety and Efficacy. Plastic & Reconstructive Surgery. 119(3):775-785, March 2007. Coleman, Sydney R. M.D.; Saboeiro, Alesia P. M.D.
© Coleman 2009