510(k) K120996

FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN by Paragon Vision Sciences — Product Code HQD

K120996 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN". The FDA issued a decision of Substantially Equivalent on June 28, 2012. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.