# K152046: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)

- Pathway: 510(k) (Traditional)
- Applicant: Art Optical Contact Lens, Inc.
- Decided: Nov 24, 2015 after 124 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 P810005 (1981). 16 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142641: Intelliwave4, Art Optical Contact Lens, Inc. (2015) Summary page 5.

## Most influential descendants
- K161100: Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (2016), 8 descendants of its own
- K213538: Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 4 descendants of its own
- K240618: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens (2024), 3 descendants of its own
- K171575: ENFLU 18 (enflufocon A) Daily Wear Contact Lens (2017), 1 descendant of its own
- K242393: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (2024), 0 descendants of its own

## Indications for use
The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error 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 Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters. The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K152046
Methodology: https://510kreport.com/methodology