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Celluma Device Gets 9th FDA Approval, Now For Facial Wrinkles
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According to the company, several other US applications for use are still pending, and additional clinical trials for “advanced therapeutic applications” are scheduled.
The US Food and Drug Administration has approved a medical device for additional uses in treating full face wrinkles.
Celluma, a series of patented light-emitting diode (LED) medical devices for peri-orbital wrinkles, acne, muscle and joint pain, muscle and joint stiffness, muscle tissue tension, muscle spasm, arthritis and compromised local blood circulation, is created by BioPhotas, Inc. It is currently approved for 9 separate FDA indications-for-use, with the most recent coming this week.
The low-level light therapy device series combines the “power and efficacy of large professional panel devices” with costliness associated with smaller hand-held devices, BioPhotas president and chief executive officer Patrick Johnson said.
“In the Celluma, we have created an extraordinarily versatile product that is effective enough to be used in a professional setting and affordable enough to be used in the home,” Johnson said.
Celluma provides care with wavelengths to receptors via blue, red and near-infrared light energy. The device invokes different cellular processes with a signaling mechanism to help treat musculoskeletal and dermatological conditions.
BioPhotas’ devices are based on National Aeronautics and Space Administration (NASA) technology, according to the company, and are dependent on clinical biophotonic capability.
Its expansion into skin, muscle and joint treatments may still not be finished at 9 approved uses. According to the company, several other US applications for use are still pending, and additional clinical trials for “advanced therapeutic applications” are scheduled.
The devices may also begin hitting overseas markets. BioPhotas has recently been granted utility patent coverage in the Europe Union and Australia regions, according to the company, and foreign patent applications are pending as well.
Johnson said the company has ongoing efforts to “register its devices and protect those devices around the world.”
“We are encouraged that the innovation in our products is recognized commercially, as well as by both global regulatory and intellectual property authorities,” Johnson said.
A press release regarding the approval was made available.
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