Healthcare Industry News:  FDA 

Devices Dermatology Product Launch

 News Release - April 28, 2022

World's First FDA-Approved Cold Ablative Fiber Laser Makes US Debut

Acclaro Corporation Launches UltraClear™ at ASLMS 2022 in San Diego, CA

SMITHFIELD, R.I. , April 28, 2022 -- (Healthcare Sales & Marketing Network) -- Acclaro Corporation, (formerly FA International LP, Boston, Mass.), breaks new ground in medical devices for aesthetics with their revolutionary UltraClear™ system. This disruptive technology features a no downtime, painless treatment to address a full spectrum of skin conditions including pigmentation, enlarged pores, fine lines, wrinkles, scars and acne scars, age spots, sun damage, textural irregularities and general complexion issues. It is safe for all skin types, including darker skin types III – VI.

According to Shlomo Assa, the inventor of UltraClear technology, "The 2910 nm wavelength is at water peak absorption and maximizes tissue ablation while minimizing the incidence of post-inflammatory hyperpigmentation (PIH) or post-inflammatory erythema (PIE), as well as bleeding. Fiber lasers are the future of laser technology because they are more reliable with superior beam quality and speed."

He continues, "What makes it 'cold' compared to other lasers is that tissue is vaporized very efficiently by the non-visible 2910 nm wavelength. There are no lingering thermal traces, reducing patient pain sensation, especially when using the superficial ablation modes of the device. In addition, UltraClear offers an innovative solution that increases clinical efficacy, improving the patient's overall experience as compared to other energy devices. The patent pending blended pulse technology 3DIntelliPulse™ creates most profound, three-dimensional collagen remodeling by automatically blending cold and thermal energy simultaneously at the same micro-ablative channels and delivering fractional coagulation at multiple skin layers to optimize efficacy while increasing safety for all skin types."

"The MIRACL™ (Mid IR Ablative Cold Fiber Laser) technology delivers superb beam quality, creating high-density matrix of spots to maximize the clinical effect while minimizing the total energy delivered. Combining high resolution ablation matrix with rapid fractionated pulsing, the laser delivers fast patterns in a fraction of the time compared with older generation lasers," says Assa.

Eric F. Bernstein, MD, Chief Medical Officer of Acclaro Corporation, and Main Line Center for Laser Surgery (Ardmore, Pa.), led a histopathology study of the effects of the UltraClear laser (publication pending). "What amazes me about UltraClear is that even with superficial injury limited to stratum corneum, we are seeing a tremendous response in the dermis and major clinical improvement. It is really quite remarkable. The laser is extremely fast. Depending on the setting, I have treated the full face in 4 minutes without pain using the 15 mm x 15 mm spot which is easy to use. Plus, the fact that we don't need to use topical anesthetic saves me an hour plus on each patient, which is a huge advantage," he says.

With no consumables or per-pulse payments, treatment times of less than 15 minutes, no topical numbing required for most procedures and full range of outcomes from true lunchtime treatments to most advanced collagen remodeling, UltraClear offers a rapid return on investment (ROI) for aesthetic providers. The unprecedented level of safety and ease of use make it prime for delegation to trained ancillary staff.

"This is a leap forward technology in my opinion. I have been very impressed with the UltraClear laser. I've been waiting for a device like this for a long time," says Dr. Bernstein.

ABOUT ACCLARO CORPORATION

Founded in 2018 by a group of world-class experts and top physicians, Acclaro Corporation is a US-based, fast-growing medical device company committed to developing game-changing solutions to address today's most challenging unmet needs in the global medical aesthetic, ophthalmic and surgical markets. With decades of pioneering renowned innovations in laser technology and medicine, aesthetic applications, dermatology research, and over 50 published patents combined, Acclaro Corporation was founded to pave the way for the next generation of advances. Our vision and unrelenting passion for medical technology innovation is to inspire confidence and trust with our physician partners globally by delivering unparalleled results, efficacy and safety to improve quality of life. www.AcclaroMD.com

ABOUT ERIC F. BERNSTEIN, M.D.

Eric F. Bernstein, M.D., M.S.E. is a world leader in dermatologic laser surgery. He served as the President of the American Society for Laser Medicine and Surgery (ASLMS), the world's premiere professional organization representing medical laser and energy-based applications, and is a director of the American Society of Dermatologic Surgery (ASDS). Dr. Bernstein is the founder and director of Main Line Center for Laser Surgery on the Main Line outside of Philadelphia and is currently clinical professor of dermatology at the Perelman School of Medicine at the University of Pennsylvania. Dr. Bernstein holds 14 U.S patents, numerous international patents for applications and has authored over 100 scientific publications.

For more information or to speak with Shlomo Assa or Dr. Eric Bernstein, press@acclaromed.com


Source: Acclaro

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