# K180004: Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Feb 22, 2018 after 51 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: 5 generations back to P810005 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 4.

## Indications for use
The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism. The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism. The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism. The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism. The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.

Source page: https://510kreport.com/device/K180004
Methodology: https://510kreport.com/methodology