# K202129: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

- Pathway: 510(k) (Traditional)
- Applicant: Largan Medical Co., Ltd.
- Decided: Apr 1, 2021 after 244 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: 7 generations back to K942214 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia, Largan Medical Co., Ltd. (2018) Summary page 5.
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan Medical Co., Ltd. (2018) Summary page 5.

## Indications for use
The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive a.metropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of l .00D or less where the astigmatism does not interfere with visual acuity. The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of a.metropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of a.metropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.

Source page: https://510kreport.com/device/K202129
Methodology: https://510kreport.com/methodology