LASEROPTEK PicoLO Laser Receives FDA 510(k) Clearance


LASEROPTEK Co Ltd announces that its PicoLO picosecond Nd:YAG laser recently received US Food and Drug Administration 510(k) clearance for use in dermatology and general and plastic surgery.

PicoLO generates high peak power and consistent picosecond pulse duration producing strong photomechanical forces within the skin to quickly and effectively break down and fragment pigments such as those found in tattoos. In addition, PicoLO incorporates LASEROPTEK’s patented Diffractive Optical Element (DOE) fractional technology consistently creating Laser-induced Optical Breakdown (LIOB) in the dermis even at low power.

This combination of photomechanical effect and LIOB gives PicoLO a significant point of difference with picosecond lasers on the market and delivers numerous advantages to both patients and providers, according to a company news release.

“Exceptionally stable energy output and picosecond pulse duration are key technological developments integrated into PicoLO further distancing it from the competition. High stability in both laser output and pulse duration is central to delivering consistently efficacious treatment outcomes while simultaneously minimizing patient discomfort,” says C.J. Lee, CEO of LASEROPTEK, in the release.

[Source(s): LASEROPTEK Co Ltd, PR Newswire]

Hologic Launches TempSure Surgical RF Technology in North America


Hologic Inc’s Cynosure division announces the North American launch of the FDA-cleared TempSure Surgical RF technology, a new offering of the TempSure radiofrequency (RF) platform that provides clinicians the ability to perform both surgical and nonsurgical aesthetic procedures across a variety of specialties, on a single device.

Cynosure also has returned TempSure Vitalia hand pieces and probes to the market and will continue to market its MonaLisa Touch CO2 laser following the US Food and Drug Administration (FDA) inquiry on products used in energy-based women’s health procedures. Over the past several months, Cynosure worked closely with the FDA and reviewed and updated all its marketing and promotional materials to ensure they are consistent with the FDA’s labeling expectations, the company explains in a media release.

TempSure Surgical RF technology harnesses a 300-watt and 4-MHz radiofrequency platform that enables precise incisions with minimal lateral thermal damage to surrounding tissues. The resulting high-quality coagulation lessens sparking and charring during procedures, which promotes quicker recovery and better healing for patients. The device is designed to improve patient satisfaction and aesthetic outcomes, and can be used by clinicians across a variety of specialties including plastic surgery, dermatology, gynecology and ophthalmology.

“We’re continually innovating to ensure our customers set themselves apart with effective and diverse treatment offerings, and this enhanced platform is a game-changer across specialties,” says Kevin Thornal, Hologic’s Division President, Cynosure, in the release. “The cutting-edge technology of the TempSure platform will now allow doctors to transition seamlessly from invasive to non-invasive treatments on one device.”

Thornal adds, “We’re pleased to reintroduce TempSure Vitalia and to continue offering MonaLisa Touch to provide clinically strong products for women’s wellness. Cynosure is the only medical aesthetic manufacturer to offer two different energy-based modalities for women’s wellness — radiofrequency and CO2 — and we remain committed to advancing women’s pelvic health around the globe.”

TempSure Surgical RF technology is designed to enhance the existing TempSure radiofrequency platform, and includes a variety of electrodes that integrate seamlessly with the main TempSure unit. In January 2018, Cynosure launched the TempSure radiofrequency platform with TempSure Envi, a device for treating facial fine lines and wrinkles, tightening the skin through soft tissue coagulation, and temporarily reducing the appearance of cellulite.

New and existing customers now have the opportunity to customize their TempSure Envi system to include TempSure Surgical RF technology, TempSure Vitalia hand pieces, or a combination of all three to help meet different clinical needs at their practice, the release continues.

[Source: Hologic Inc]

Sciton Introduces the ALLURA Submental Contouring Laser

ALLURA Neck Sciton

Sciton announces the release of ALLURA, a micro-invasive laser module for rapid fat reduction and skin contraction in the submental, neck, and chin area.

“ALLURA Neck is all about rapid contour results with a single, office-based treatment,” says Marc Salzman, MD, a plastic surgeon in Louisville, KY, in a media release from Palo Alto, Calif-headquartered Sciton.

“It fits perfectly into my practice, next to non-invasive modalities like CoolSculpting Mini and Kybella. These procedures have the limitations of taking several months and sessions to attain modest results. With ALLURA Neck, the outcomes are profound within two weeks, 100% of the time. In addition, it is a high ROI procedure,” he adds.

“We’ve found that ALLURA captures an attractive, distinct patient profile,” remarks Aaron Burton, chief operating officer of Sciton, in the release. “Many patients want fast, visible results in a one-and-done treatment. To provide this option, our customers have urged us to revitalize a proven procedure with new simplified features, protocols and branding. We’ve done that with ALLURA and believe it’s a great addition to our Joule platform.”

“I leverage my patient base, and they love that I have alternatives for them,” adds Jared Mallalieu, DO, a cosmetic surgeon in Severna Park, MD.

“In consultations, and also for new patients, they often have wrong assumptions and incomplete understanding. Many opt for ALLURA when they got the whole picture with all major pros and cons, including results versus time and cost.”

ALLURA Neck can be added to the Sciton JOULE platform, according to the company. The JOULE platform is an expandable platform that is engineered to offer an array of laser and light wavelengths through delivery modes such as arm, fiber and BroadBand Light.

[Source(s0: Sciton, PR Newswire]

Sciton Announces New Multi-Center Clinical Study On HALO

Sciton announces the publication of a new multi-center clinical study, “Hybrid Fractional Laser: A Multi-Center Trial on the Safety and Efficacy for Photorejuvenation,” in the November issue of the Journal of Drugs in Dermatology (JDD) in a special issue for lasers, light sources, and devices.

“This study further proves that the HALO Hybrid Fractional Laser offers a safe and effective treatment for a multitude of skin conditions on the face and neck while giving patients the results they desire with limited downtime,” says Jill Waibel, MD, Miami Dermatology and Laser Institute, in a media release from Sciton.

“We are proud to offer our customers, patients, and business partners substantial clinical evidence that the HALO Hybrid Fractional Laser delivers high patient satisfaction, results they demand, and with the minimal downtime they expect,” states Lacee J. Naik, Director of Global Marketing

The HALO Hybrid Fractional Laser is designed to apply tunable non-ablative (1470nm) and ablative (2940nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime and produce targeted, reproducible, effective results that improve the appearance of numerous skin conditions.

Intelligent energy delivery, combined with Dynamic Thermal Optimization, ensures precise, even, safe treatments. As part of the multifaceted, expandable JOULE platform, HALO provides the practitioner with a dynamic and essential component of their aesthetic toolbox, the release continues.

[Source(s): Sciton Inc, PR Newswire]

Lumenis Introduces SPLENDOR X Laser Hair Removal Solution at ASDS

Lumenis Ltd launched SPLENDOR X— a solid state laser system equipped with the unique BLEND X technology for fast and effective hair removal and skin solutions recently during the 2018 American Society of Dermatological Surgery – ASDS in Phoenix.

SPLENDOR X is engineered to treat a wide range of hair removal procedures, with BLEND X, bilateral laser emission of Nd: YAG (1064nm) and Alexandrite (755nm) wavelengths, synchronized to fire with adjustable proportions. At 250W output power, SPLENDOR X provides rapid coverage rate combining high fluency, large spot size and high repetition rate. The unique square spot shape eliminates overlap and hot spots, guaranteeing uniform skin coverage. Furthermore, a built-in plume evacuator ensures a smoke free and safer environment.

“The SPLENDOR X technology not only allows the use of the laser on all other skin tones, but due to its unique BLEND X technology, I’m able to create customized treatment options for patients of all skin types and hair types,” says Dr Suzanne L. Kilmer of Laser and Skin Surgery Center in Northern California, in a media release from Lumenis Ltd. “The two adjustable wavelengths, Nd: YAG and Alexandrite, allow me to use the machine to fit treatment requirements to each individual.”

Lumenis showcased SPLENDOR X during its Hot Topic Symposium at ASDS. In addition, Dr Mary Lupo introduced the SPLENDOR X during a lecture titled The Splendor of Hair Removal with NEW Synchronized Emissions & Square Spot + Body, which took place at the ASDS meeting.

During the lecture, she highlighted the device’s innovations, such as its ability to provide deeper penetration giving uniform coverage of the treatment area quickly and safely on all skin types including tanned and darker skin tones all year round, according to the release.

“The SPLENDOR X the next generation in hair removal and truly expands our offering in this category,” states Tzipi Ozer-Armon, CEO of Lumenis, in the release. “As with all our products, and this one specifically, we look not only to build technology, but also to create, design and inspire confidence for our customers.”

[Source(s): Lumenis Ltd, PR Newswire]

Thermi Debuts ARVATI Radiofrequency Platform

Thermi, an Almirall S.A. company, introduces ARVATI, its next-generation 510K FDA-cleared, true temperature-controlled radiofrequency platform with patented technology that powers a range of Thermi’s unique and comprehensive procedures that is now commercially available in the United States.

ARVATI delivers rapid, precise, and consistently controlled output of radiofrequency to tissue, thus inducing positive tissue change by stimulating collagen production to enhance various skin areas, including intimate tissue. The ARVATI platform is built upon increased power as well as optimized two-way real time temperature-controlled algorithms.

The new ARVATI platform includes the well-established treatment applications of ThermiTight, ThermiRase, ThermiSmooth Face and ThermiVa, used by clinicians to address common signs of aging, and/or weight loss, which may include fine lines, post-baby body, loose skin, and intimate tissue laxity.

Read the full press release at

Cutera Launches truSculpt iD, Personalized Body Sculpting

Cutera Inc announces the availability of truSculpt® iD, the next evolution in body sculpting with unique hands-free capability and the ability to treat a full abdomen in as little as 15 minutes.

truSculpt® iD’s sleek design and comprehensive handpiece options give physicians and other qualified practitioners the flexibility to deliver personalized body sculpting to patients through either a hand-held or hands-free treatment technique in a fraction of the time required by other body sculpting options on the market. This, alongside its unique ability to treat various fat densities and all skin types, highlights the versatility of the truSculpt® iD technology.

A non-surgical body sculpting system, truSculpt® iD uses innovative monopolar radio frequency (RF) technology to selectively target fat and therapeutically heat it until fat cells are slowly removed and excreted through the body naturally. Penetrating deep to treat the entire fat layer from skin to muscle, truSculpt® iD is clinically proven for permanent fat cell destruction. With real-time temperature control working to provide consistent results, studies have shown an average fat reduction of 24 percent, with patients seeing improvements 6-12 weeks following the first treatment.

“truSculpt® iD allows patients to achieve truly tailored results in a significantly shorter time frame, making it a very appealing non-invasive option for permanently eliminating fat cells in stubborn areas,” comments Dr Anne Chapas, dermatologic surgeon and Medical Director of Union Square Laser Dermatology. “With such an efficient technology and the ability to treat multiple body areas simultaneously, we are able to treat more patients in a shorter period of time as a result.”

“We are proud to announce the availability of truSculpt® iD, supporting our mission to develop powerful technologies that advance the medical aesthetics industry and help clinicians expand their body sculpting practice,” states James Reinstein, President and CEO of Cutera Inc.

“truSculpt® iD delivers results regardless of the patient’s shape or body type – allowing physicians to effectively treat those who might not be candidates for other contouring procedures. We believe the truSculpt® iD will expand the market with this comfortable, safe, and highly accelerated sculpting procedure. Additionally, truSculpt® iD further enhances our expanding portfolio of devices which incorporate a disposable element. These new consumables allow us to participate in procedure-based recurring revenue along with our physician customers.”

The launch of truSculpt® iD comes at a time of significant growth for the industry. Research shows non-surgical fat reduction was the top non-surgical and non-invasive procedure in 2017, with procedures increasing by 24.7%. Looking ahead, the body shaping and skin tightening market is expected to expand by 14.5% year-over-year.

[Source: Cutera Inc]