510(k) · Cleared

Cleared

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact Lenses

K071203510(k) TraditionalCleared Jun 13, 200743-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

Optikem International, Inc. · LPN Accessories, Soft Lens Products

Cleared on Jun 13, 2007 as substantially equivalent to K011561 (Wilsa, Inc., 2001) after a 43-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jun 13, 2007
Review: 43 days
Class: Class II
Product code: LPN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011561 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011561 Sereine Extra Strength Daily CleanerWilsa, Inc. · 2001
This deviceK071203 Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy)…Optikem International, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011561	Sereine Extra Strength Daily Cleaner	Wilsa, Inc.	2001	—
0 (this device)	K071203	Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact…	Optikem International, Inc.	2007	—

FIG. 1 — Lineage of K071203, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011561	Sereine Extra Strength Daily Cleaner Summary page 4 …met ISO requirements for Cytotoxicity. All other safety and efficacy data can be referenced in previously cleared 510(k) KOl 1561. Permission to reference 510(k) K01 1561 is included in this 510(k). Substantial Equivalence: The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Sof…	Wilsa, Inc.	2001	—
*	—	MIRAFLOW cleaner by CIBA Vision Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

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.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · LPN

2in 2022

2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007high 222 (2011) · low 59 (2016)2026

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

Recalls per year · LPN

1in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	175	2	1,151
2008	0	—	0	153
2009	1	—	2	121
2010	2	—	2	241
2011	3	222	1	273
2012	2	—	0	268
2013	2	—	0	84
2014	0	—	0	105
2015	2	—	0	176
2016	3	59	1	498
2017	1	—	0	2,666
2018	0	—	0	95
2019	2	—	0	60
2020	3	167	1	82
2021	2	—	0	51
2022	2	—	0	62
2023	0	—	0	84
2024	0	—	0	76
2025	0	—	0	40
2026	1	—	0	—

What is it indicated for?

The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner

for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft

contact lenses during wear.

Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used

with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the

recommendation of your eye care practitioner when disinfecting your lenses.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071203 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071203: Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071203

Report an extraction error

Are you the manufacturer?

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