510(k) Report

510(k) · Cleared

Cleared

Eye See Multipurpose, NO-Rub Contact Lens Solution

K051104510(k) TraditionalCleared May 31, 2006394-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lapis Lazuli, NV · LPN Accessories, Soft Lens Products

Cleared on May 31, 2006 as substantially equivalent to K030092 (Advanced Medical Optics, Inc., 2003) after a 394-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided
May 31, 2006
Review
394 days
Class
Class II
Product code
LPN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K030092 (2003). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant clearedK030092 · Complete Brand Multi-Purpose Solution · Advanced Medical Optics, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K030092 · Complete Brand Multi-Purpose Solution · Advanced Medical Optics, Inc. · 20030
  1. Root · 1 generation backK030092 Complete Brand Multi-Purpose SolutionAdvanced Medical Optics, Inc. · 2003
  2. This deviceK051104 Eye See Multipurpose, NO-Rub Contact Lens SolutionLapis Lazuli, NV · 2006
  3. Descendant · cites it directly · 0 of its ownK070767 Eye See Multipurpose Contact Lens SolutionLapis Lazuli International NV · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K070767Eye See Multipurpose Contact Lens SolutionLapis Lazuli International NV · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030092Complete Brand Multi-Purpose SolutionAdvanced Medical Optics, Inc.2003—
0 (this device)K051104Eye See Multipurpose, NO-Rub Contact Lens SolutionLapis Lazuli, NV2006—
+1K070767Eye See Multipurpose Contact Lens SolutionLapis Lazuli International NV2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K051104, 2003–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LPN? 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 LPN device

  1. #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K030092Complete Brand Multi-Purpose Solution
Summary page 3
…rms of its actions and indications for use to the following predicate devices: PREDICATE DEVICES "Complete®" brand Multi-purpose solution by Advanced Medical Optics K030092 "NRC07" Multi-purpose solution by Bausch & Lomb K033854 The EYE SEETM Multipurpose, Contact Lens Solution meets the guideline…
Advanced Medical Optics, Inc.2003—
Kept off the family treeK033854NRC07 Multi-purpose solution
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 3
…predicate devices: PREDICATE DEVICES "Complete®" brand Multi-purpose solution by Advanced Medical Optics K030092 "NRC07" Multi-purpose solution by Bausch & Lomb K033854 The EYE SEETM Multipurpose, Contact Lens Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Pre…

Also cleared against K030092: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070767Eye See Multipurpose Contact Lens SolutionLapis Lazuli International NV20070

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070767 (Lapis Lazuli International NV, 2007) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K030092.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPN

2in 2022

2007: 42009: 12010: 22011: 32012: 22013: 22015: 22016: 32017: 12019: 22020: 32021: 22022: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007: 175 days median2011: 222 days median2016: 59 days median2020: 167 days median
2007high 222 (2011) · low 59 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPN

1in 2020

2007: 22009: 22010: 22011: 12016: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPN

40in 2025

2007: 1,1512008: 1532009: 1212010: 2412011: 2732012: 2682013: 842014: 1052015: 1762016: 4982017: 2,6662018: 952019: 602020: 822021: 512022: 622023: 842024: 762025: 40
2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007417521,151
20080—0153
20091—2121
20102—2241
201132221273
20122—0268
20132—084
20140—0105
20152—0176
20163591498
20171—02,666
20180—095
20192—060
20203167182
20212—051
20222—062
20230—084
20240—076
20250—040
20261—0—

What is it indicated for?

EYE SEETM Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, as recommended by your eye care practitioner.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K051104: Eye See Multipurpose, NO-Rub Contact Lens Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051104

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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