K-number	K244009
Device name	Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
Applicant	Yung Sheng Optical Co., Ltd.
Product code	LPL
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	886.5925

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Pure Plus UV Aspheric (Otufilcon A) is a silicone hydrophilic soft contact lens available in two forms: a reusable daily wear version and a single-use daily disposable version. It is indicated for correcting myopia and hyperopia in persons with non-diseased eyes, including those with up to 2.00 diopters of astigmatism.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)

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