Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric

Precision1 and Dailies Total1 are daily disposable soft contact lenses made from verofilcon A and delefilcon A materials respectively. They are indicated for optical correction of refractive errors (myopia and hyperopia) in persons with non-diseased eyes, with various options for astigmatism correction and multifocal designs. The lenses are single-use, meant to be discarded after one day of wear without cleaning or disinfection.

The devices are modifications of existing predicate devices with no changes to lens material, design, or optical properties. The modification involves only the extraction and coating processes during manufacturing. The lenses maintain the same spherical, toric, multifocal, and multifocal toric designs as their predicate counterparts.

Not stated in this summary.

The applicant demonstrates substantial equivalence through non-clinical bench testing showing that lenses manufactured with the modified extraction and coating processes meet all established finished product specifications for optical, dimensional, and surface properties as well as extractables and residuals. Since there are no device modifications—only manufacturing process changes—and the modified lenses perform identically to predicate devices per specification testing, they are substantially equivalent to Precision1 (K233856) and Dailies Total1 (K232921).