Tattoo-removal: Cynosure wins FDA nod for PicoSure laser workstation

December 5, 2012 By MassDevice staff Leave a Comment

Aesthetics devices maker Cynosure (NSDQ:CYNO) received FDA clearance for its PicoSure laser workstation, a device designed for the removal of tattoos and benign pigmented lesions.

The study based on 22 people demonstrated greater than 80% overall tattoo clearance, and 94% removal for blue and green ink over 2 weeks, according to a press release.

"FDA clearance of PicoSure is a major milestone that caps nearly a decade of research and development at Cynosure to commercialize the world’s first safe and effective picosecond aesthetic laser specifically designed for the removal of tattoos and benign pigmented lesions," president & CEO Michael Davin said in prepared remarks. "PicoSure accomplishes this by delivering short-pulse bursts of energy to the skin in trillionths of a second."

Approximately 20% of the 45 million Americans with tattoo want it removed and the device could "treat a large and vastly underserved market," Davin added.

The Westford-based company Cynosure plans to launch the product in the U.S. at the beginning of next year to aesthetic dermatologists and plastic surgeons.

The FDA in July cleared Cynosure’s home anti-wrinkle device for over-the-counter sales. The company planned to launch sales in 2013 for the home-use anti-facial wrinkle device.

See the next generation of leaders at DeviceTalks Minnesota!

On June 4-5, DeviceTalks is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring, bringing you the best and brightest minds in the industry.

KEYNOTE SPEAKERS

Heidi Dohse: Sr. Program Manager, Healthcare, Google, Founder, Tour de Heart Foundation, Acessa Health Inc. Michael J. Pederson: Senior Vice President, Cardiac Arrhythmias and Heart Failure Division, Abbott Hon. Melvin Carter: Mayor, Saint Paul Tim Philips: Compliance Officer, FDA’s Office of Medical Device and Radiological Health Operations Dr. Myriam J. Curet, MD, FACS: Chief Medical Officer, Intuitive Surgical

Take a look at our incredible line up of speakers and join us now.

Use the code "KEYNOTE" to save 15% on the cost of registration.

REGISTER TODAY

4 ways medtech contractors are evolving (and why)
The present and near future for medtech contractors will rely on specific strategies such as tiered partnerships and consolidation, an emphasis on speed, and owning therapeutic and technology spaces. Andrew Potter, Bonifacio Consulting Services, and Christopher Delporte In the first article in this series, we examined some of the important trends during the last 10–15 years […]
Minnesota’s Medical Alley has a big presence at EuroPCR
The Medical Alley Association in Minnesota is touting the major presence that companies and organizations from the state will have at this year’s EuroPCR, which is being held this week in Paris. The event — the European Association of Percutaneous Cardiovascular Interventions’ annual meeting — is May 22–25 at the Palais des Congrès and is expected to […]
Will FDA turn to neuroscience-based human factors research?
There is a new wind blowing in medical technology — one that many believe is overdue: an overhaul of human factors. At the recent Patient Safety Initiative, Charles Murphy, Chief Patient Safety Officer at the Inova Heart and Vascular Institute, called out human factors as one of the key factors he believed needed to be […]
High-volume manufacturing: Essential points to consider before you scale up
High-volume manufacturing typically involves the introduction of automation into the medical device fabrication and assembly process. A number of benefits usually follow: repeatability, heightened quality and lower (and more predictable) long-term costs of operation. Download the B. Braun Medical white paper. The post High-volume manufacturing: Essential points to consider before you scale up appeared first […]
C&K launches autoclave-safe medical switch product line
C&K announced that it has launched its medical switch product line of autoclave-safe switches. The new medical switches are designed to meet industry sterilization standards that protect patients from risks that comes from reusable tools. Sterilization helps prevent contamination from fluid and contagion ingress. “Medical device engineers are creating the applications that people entrust to […]
Can Minnesota become a healthcare innovation hub?
Minnesota has the institutions and the talent to transform healthcare in the U.S. The question is whether the money will follow. RxFunction makes wearable devices called “Walkasins” that help people with chronic health conditions prevent falls that can lead to serious injury. It took eight painstaking years, though, before the Eden Prairie, Minn.-based startup secured […]
Medtech Association to host inaugural MedTechIDEAS Summit
The Medtech Association is hosting its inaugural MedTechIDEAS Summit on May 31 in Skaneateles Falls, N.Y. The event will take place at 11 a.m. until 5:30 p.m. at the Lodge at Welch Allyn. The MedTechIDEAS Summit is a quarterly conference series that presents a “big idea” in healthcare from an industry thought leaders while delivering […]
Triton to sell Aventics company to Emerson
Triton recently announced that it plants to sell its Aventics pneumatics company to Emerson. The financial details of the deal were not disclosed. Emerson and Triton recently came to an agreement and the transaction is in progress, starting with the regulatory approval process that is currently underway. Aventics serves the life sciences industry by providing […]
Grayhill launches Touch Encoder Development Kit
Grayhill recently launched its Touch Encoder Development Kit that gives product development engineers simplified designs for medical applications. The new development kit features tap, swipe and turn functions that gives designers the opportunity to replace traditional user-input devices. Using a tablet development app, product development engineers can personalize multi-touch gestures, create images and customize the […]
Webinar: How to balance regulations and performance with your medical device design
Wednesday, June 20, 2018 2 p.m. Eastern time / 11 a.m. Pacific time Creating a medical device that meets both regulatory compliance and performance requirements takes careful planning. You also need to understand the most efficient path to market commercialization in order to stay within budget and on schedule. This is no simple […]
Diversified Plastics expands sales engineer and technical support team
Diversified Plastics (Minneapolis) recently announced that it has added three new sales engineer and technical support members to its team. Raymond Schenk has joined Diversified Plastics as senior sales engineer. He has over 24 years of experience in the plastic industries and will be responsible for the western territories of the company. Prior to joining the […]