SpectrumEX™
OptMed’s methylidene malonate-based topical skin adhesive received 510(k) marketing clearance from the FDA in 2015.
Since receiving marketing clearance, OptMed has scaled up its manufacturing process in its own manufacturing facility and implemented various changes to the chemistry and the delivery device. We've given BondEase™ a new name to reflect these changes-
SpectrumEX™
The new manufacturing process for SpectrumEX™ will require a modified 510(k) clearance from the FDA. OptMed intends to file a 510(k) application for SpectrumEX™, leveraging the already cleared BondEase™ as the predicate device for our application.
Cartridge with activator tip containing a vial of methylidene malonate monomer with precision pen.
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Sets and dries quickly to save time
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Generates minimal heat during polymerization
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Enables precision application of adhesive via pen-like device handle
SpectrumEX™ product is a topical, biocompatible, skin adhesive comprised of a methylidene malonate monomer technology. This adhesive is delivered with an ergonomic, user-friendly device, providing easy and predictable application of SpectrumEX for a wide variety of clinical challenges.