OmniGuide Holdings Receives FDA Clearance for RevoLix™ HTL Hybrid Thulium Laser for the treatment of BPH and Stones
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Thursday, May 26, 2022
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OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix HTL a family of pulsed and continuous wave Thulium YAG lasers is the foundation of RevoLix Therapy for urology patients undergoing BPH and Stone Management procedures.
Key Points:
- OmniGuide Holdings (OGH) Today, the U.S. Food and Drug Administration cleared RevoLix HTL a family of pulsed and continuous wave Thulium YAG lasers is the foundation of RevoLix Therapy for urology patients undergoing BPH and Stone Management procedures.
- At the same time, patent pending HTL technology allows for stone clearance without overheating stone and urine medium.
- The FDA cleared Revolix HTL, LISA Laser GmbH a Division of OmniGuide Holdings Inc., through the 510(k) premarket clearance pathway.
- With over 600 peer reviewed clinical articles and 31 years of surgical Thulium laser research and development experience, RevoLix and OmniGuide look forward to serving patients and their Urologist here in the United States, said Carlos Acosta Global Director of RA QA OmniGuide Holdings.