# K030748: Aquasoft (Ocufilcon D) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Clearlab Pte, Ltd.
- Decided: May 14, 2003 after 65 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K942214 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982947: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens, Ocular Sciences Puerto Rico, Inc. (1999) Summary page 2.
- K011542: Specialty D-UV (Ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear, Specialty D-UV Multifocal (Ocuflicon D), Specialty Ultravision, Inc. (2001)

## Indications for use
The AQUASOFT (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. The AQUASOFT (ocufilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. The AQUASOFT (ocufqcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00Dand have near add requirements up to 3.00D. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for daily wear for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for fiequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K030748
Methodology: https://510kreport.com/methodology