# K210930: ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Nov 29, 2021 after 245 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042275 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042275: Vistakon (Senofilcon a) Soft Contact Lens, Vistakon (2004) Summary page 4.

## Recalls of this device
- Jun 12, 2025 · Class II · Z-2163-2025: Due to defects (bubbles/voids) identified during standard finished goods testing

## Indications for use
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (myopic) or farsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity. ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism. ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity. ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism. The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.

Source page: https://510kreport.com/device/K210930
Methodology: https://510kreport.com/methodology