# K120756: LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE

- Pathway: 510(k) (Traditional)
- Applicant: The Lagado Corp.
- Decided: May 13, 2013 after 426 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: 1 generation back to K964528 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint, Benz Research and Development Corp. (1997) Summary page 1.

## Most influential descendants
- K133079: IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric (Mangofilcon a) Soft (Hydrophilic) (2013), 1 descendant of its own
- K142820: BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear (2015), 0 descendants of its own

## Indications for use
The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters. The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters. The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters. The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters. The lenses may be disinfected using chemical (not heat) disinfecting systems.

Source page: https://510kreport.com/device/K120756
Methodology: https://510kreport.com/methodology