PARK CITY, UTAH, USA, June 30, 2022 /EINPresswire.com/ — It has recently come to light that a company named Sentient Lasers LLC, located in Utah, has been marketing and selling a Sentient Sculpt without a proper FDA approval or clearance. This may be considered as huge violation of federal law and could result in serious penalties for the company. It is important to note that only devices with proper FDA approval clearance may be marketed and sold in the United States. Devices not approved by the FDA may harm consumers and even lead to death.
Sentient Sculpt appears to be a copy of Deka Onda, a body contouring device that uses microwaves for body contouring (Coolwaves). Sentient Laser website states that Sentient sculpt’s is FDA-cleared, without discussing treatment’s mechanism of action or any potential side effect. Moreover, it makes an unsubstantial claim the Sentient Sculpt is the only device that in addition, it does not mention or refer to the Deka Onda device. In contrast, the Deka Onda website contains a wealth of information regarding the device, its indication, and its mechanism of action. In addition, it is explicitly stated that Deka Onda is not FDA-approved!
“The issue is that multiple clinics promote the Sentient Sculpt as the only FDA-approved device that uses coolwave for cellulite treatment,” said Dr. Alhallak, director of the Albany Cosmetic and Laser Centre. “In fact, Sentient Lasers website promotes the device as FDA-cleared and some of their social media acounts emphasis the FDA aproval. However, there is no such device in the FDA medical devices database.” A regiours search showed that the only FDA clearance Sentient Lasers has is K213554 for a Laser Fiber System identical to Quanta Laser Fiber System. A Google Scholar search showed only one prospective pilot study performed in Italy entitled “Combined microwaves and fractional microablative CO2 laser treatment for postpartum abdominal laxity” on only Fifteen women. “This could be effective new piece of technology. However, it may lack the proper safety and regulatory documentation” Said Dr. Hallak
Aesthetic devices must be FDA cleared or approved because they can pose a risk to consumers if they are not. These devices can be harmful and, in some cases, deadly. The FDA has a rigorous process for approving or clearing devices, and only those that meet their standards may be marketed and sold in the United States.
The FDA 510(k) Clearance is a process by which the FDA evaluates medical devices to ensure that they are safe and effective for human use. Devices not cleared or approved by the FDA may harm consumers and even lead to death. This process makes it easier to market a device if the submitters can compare their equipment to one or more comparable lawfully marketed devices and establish and justify significant equivalence claims. A legally marketed device is a device that was legally marketed before May 28, 1976 (preamendment device), a device that has been reclassified from Class III to Class II or I, a device that has been determined to be SE through the 510(k ) process, or a device that has been granted authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act and is not exempt from premarket notification requirements.
“In my professional view, this is not the case with the Deka Onda or Sentient Sculpt since it is the first aesthetic device to employ 2.4 GHz microwaves radiation, which implies it is not exempt from clearance and will need a complete approval procedure,” added Dr. Hallelujah.
Sentient Lasers also market and sell the Tixel device, which claims to be the only device to provide skin resurfacing to all skin types via unique thermo-mechanical ablation. However, Tixel has 510(k) Premarket Notification # K202988, which questions the claim that Tixel is unique and not similar to predicate Devices such as Venus Concept USA Ltd., Venus Viva SR Device (K150161) (Predicate Device), CONMED Altrus® Thermal Tissue Fusion System (K101534) (Reference device).
Mr. Shavit, Novoxel chairman, replied to an email inquiry and stated that “Tixel® is a registered trademark of Novoxel Ltd in USA and Sentient is the authorized exclusive distributor of Texel® in USA. Texel® employs a thermo-mechanical tip to transfer heat in a fractional manner to tissue. Other devices that you refer to do not employ the same mechanism. For example, Venus Viva employs a tip which uses RF energy. Texel®, including the thermo-mechanical mechanism are patent protected in USA. TMA® is also a registered tradename of Novoxel Ltd.”
Sentient Lasers LLC refused to comment, and did not confirm or denied that Sentient Sculpt TM lack the proper FDA clearance. We reached out to Deka but we have not received a response. Therefore, the safety issue was reported to the Center for Devices and Radiological Health at the FDA with all proper documentation.
Dr. Kamal alhallak
Albany Cosmetic and Laser Center
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