510(k) · Cleared
ClearedLSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Lagado Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 13, 2013 as substantially equivalent to K964528 (Benz Research and Development Corp., 1997) after a 426-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- May 13, 2013
- Review
- 426 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964528 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964528 (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft…Benz Research and Development Corp. · 1997
- This deviceK120756 LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH…The Lagado Corp. · 2013
- Descendant · cites it directly · 1 of its ownK133079 IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily…Alden Optical Labs., Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142820 BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for…Abb Optical Group, LLC · 2015
Most influential descendants
Showing 2 of 2 · See all- K133079IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric…Alden Optical Labs., Inc. · 2013 · cites it directly1descendant
- K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS…Abb Optical Group, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)… | Benz Research and Development Corp. | 1997 | — |
| 0 (this device) | K120756 | LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon… | The Lagado Corp. | 2013 | — |
| +1 | K133079 | IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2… | Alden Optical Labs., Inc. | 2013 | — |
| +1 | K142820 | BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear… | Abb Optical Group, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 1…es Lagado Corporation claims substantial equivalence to Benz- 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens as cleared for marketing in the United States in K964528 on March 10, 1997. Lagado Corporation K120756 Pa… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
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…
Read the full statement (227 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120756: LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120756
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026