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510(k) Data Aggregation
(88 days)
The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.
The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.
The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.
Soft (hydrophilic) Contact Lens
I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets such criteria, nor does it include details about artificial intelligence, human readers, or ground truth establishment. Therefore, I cannot generate the requested table and information based on the given input.
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