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STRATA Skin Sciences Announces 510(k) Submission for its Multi Micro Dose™ Tip Accessory for the XTRAC® 308nm Excimer Laser
Jun. 19, 2018 08:46AM PST
Medical Device InvestingSTRATA Skin Sciences (NASDAQ:SSKN) Has announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its Multi-Micro Dose tip accessory for the proprietary XTRAC 308nm excimer laser. As quoted in the press release: “This is an important milestone for the Company and is the first step in our plan to introduce …
STRATA Skin Sciences (NASDAQ:SSKN) Has announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its Multi-Micro Dose tip accessory for the proprietary XTRAC 308nm excimer laser.
As quoted in the press release:
“This is an important milestone for the Company and is the first step in our plan to introduce the Optimal Therapeutic Dose™ treatment protocol, to provide faster patient outcomes, higher patient satisfaction, and to drive more patients to our partner clinics,” said Dr. Dolev Rafaeli, Chief Executive Officer of STRATA. “With its ability to apply simultaneous doses of energy to the psoriatic plaque, the MMD tip, when cleared, will allow physicians to optimize treatments more quickly. We look forward to introducing the MMD Tip upon FDA clearance.”
The patent pending MMD Tip applies multiple high-energy doses at varying levels of energy to the patient’s psoriatic plaque. Data have shown that higher doses of the XTRAC treatment achieved PASI-75 clearance in as little as two to four weekly treatments, as compared to an average of 6.2 treatments in previously published studies.
