UserWise, LLC Celebrates Role in Norlase Obtaining 510(k) Clearance and CE Mark Approval
San Jose, CA, June 23, 2023 --(PR.com)-- UserWise, LLC, a San Jose-based human factors consultancy, is pleased to announce its instrumental role in obtaining FDA 510(k) clearance and CE Mark approval for the Norlase ECHO™ Green Pattern Laser photocoagulator.
UserWise began working with Norlase in 2018 to develop and execute the human factors program for the Norlase Leaf, securing a 510(k) in July 2022. The Norlase Leaf was the first-ever FDA-cleared voice-controlled energy-emitting ablation device, opening the door for additional voice-operated medical devices in the future. Shannon Clark (Founder, UserWise) was influential in FDA negotiations to access the market, and Norlase awarded UserWise “#1 Human Factors Partner.”
UserWise supported Norlase with Risk Management, Usability Testing, and human factors regulatory strategy consulting.
Norlase, a leading global ophthalmic laser manufacturer renowned for its innovative laser solutions, recently achieved a remarkable milestone. Earlier this month, the company proudly revealed that the ECHO™ Green Pattern Laser photocoagulator has successfully obtained FDA 510(k) clearance and CE Mark approval. The ECHO™ laser sets a new industry standard as a portable scanning laser photocoagulator, seamlessly integrating laser and scanner functionalities into a single delivery device that is compatible with slit lamps. Notable features of this groundbreaking device include an integrated design with no external fiber, a wireless user interface, µSec Mode for tissue-sparing treatment, and voice control of patterns and parameters. Importantly, the ECHO's affordability democratizes pattern scanning technology, empowering doctors worldwide to deliver efficient treatments and enhance patient throughput.
UserWise has continued to support Norlase over the years, and most recently, UserWise's human factors team conducted an expert review to assess the user interface and risk profile of the Norlase ECHO™ in comparison to the Norlase LEAF.
Thanks to UserWise's expert evaluation and the established equivalence between the Norlase ECHO™ and the Norlase LEAF, Norlase successfully obtained FDA 510(k) clearance and CE Mark approval for the ECHO™ Green Pattern Laser photocoagulator.
About UserWise: UserWise, a ClariMed, Inc. company, is a dedicated San Jose-based human factors consultancy committed to improving outcomes for medical products through human factors and usability engineering. With a deep understanding of human-centered design, testing, and engineering, UserWise ensures the development of best-in-class medical products that deliver unrivaled and safe medical innovation. For more information, visit www.userwiseconsulting.com.
About ClariMed: ClariMed, a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers, offers best-of-breed professional services to cultivate innovation while ensuring the safe and effective use of medical products. Learn more about ClariMed at www.Clarimed.com.
UserWise began working with Norlase in 2018 to develop and execute the human factors program for the Norlase Leaf, securing a 510(k) in July 2022. The Norlase Leaf was the first-ever FDA-cleared voice-controlled energy-emitting ablation device, opening the door for additional voice-operated medical devices in the future. Shannon Clark (Founder, UserWise) was influential in FDA negotiations to access the market, and Norlase awarded UserWise “#1 Human Factors Partner.”
UserWise supported Norlase with Risk Management, Usability Testing, and human factors regulatory strategy consulting.
Norlase, a leading global ophthalmic laser manufacturer renowned for its innovative laser solutions, recently achieved a remarkable milestone. Earlier this month, the company proudly revealed that the ECHO™ Green Pattern Laser photocoagulator has successfully obtained FDA 510(k) clearance and CE Mark approval. The ECHO™ laser sets a new industry standard as a portable scanning laser photocoagulator, seamlessly integrating laser and scanner functionalities into a single delivery device that is compatible with slit lamps. Notable features of this groundbreaking device include an integrated design with no external fiber, a wireless user interface, µSec Mode for tissue-sparing treatment, and voice control of patterns and parameters. Importantly, the ECHO's affordability democratizes pattern scanning technology, empowering doctors worldwide to deliver efficient treatments and enhance patient throughput.
UserWise has continued to support Norlase over the years, and most recently, UserWise's human factors team conducted an expert review to assess the user interface and risk profile of the Norlase ECHO™ in comparison to the Norlase LEAF.
Thanks to UserWise's expert evaluation and the established equivalence between the Norlase ECHO™ and the Norlase LEAF, Norlase successfully obtained FDA 510(k) clearance and CE Mark approval for the ECHO™ Green Pattern Laser photocoagulator.
About UserWise: UserWise, a ClariMed, Inc. company, is a dedicated San Jose-based human factors consultancy committed to improving outcomes for medical products through human factors and usability engineering. With a deep understanding of human-centered design, testing, and engineering, UserWise ensures the development of best-in-class medical products that deliver unrivaled and safe medical innovation. For more information, visit www.userwiseconsulting.com.
About ClariMed: ClariMed, a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers, offers best-of-breed professional services to cultivate innovation while ensuring the safe and effective use of medical products. Learn more about ClariMed at www.Clarimed.com.
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UserWise, LLC
Chris Jakubowski
1-833-873-7947
www.userwiseconsulting.com
Chris Jakubowski
1-833-873-7947
www.userwiseconsulting.com
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