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FDA approval News
FDA Approves Quantel Devices
CLERMONT-FERRANC, France, Aug. 1, 2017 — Ophthalmic medical device developer Quantel Medical has received approval from the U.S. Food and Drug Administration for its Easyret fully integrated, 577-nm yellow photocoagulator, used to treat certain forms of macular edema and peripheral retinal...
Spectranetics Device Wins Approval
Jul 1, 2012 — Spectranetics Corp. of Colorado Springs, Colo., has received FDA approval for its GlideLight Laser Sheath for cardiac lead removal. GlideLight requires 55 percent less force to advance than the company’s SLS II laser sheath, which, in turn,...
VivoSight Gains 510(k) Clearance
ORPINGTON, UK, Jan. 15, 2010 -- The London-based developer and manufacturer of Optical Coherence Tomography (OCT) products, Michelson Diagnostics Ltd. has been awarded 510(k) clearance from the US Food & Drug Administration (FDA) for its VivoSight OCT scanning product. The...
Canada Clears Cutera YSGG Laser
Oct 3, 2007 — Cutera Inc., a Brisbane, Canada-based provider of laser and other light-based aesthetic systems, announced it has been granted Health Canada approval for its Pearl YSGG (yttrium scandium gallium garnet) laser. Kevin Connors, president and CEO of...
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April 2024
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