510(k) · Cleared

Cleared

Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (HYDROPHILIC0 Contact Lens

K991550510(k) TraditionalCleared May 14, 199910-day reviewClass II21 CFR 886.5925

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

Wesley Jessen Corp. · LPL Lenses, Soft Contact, Daily Wear

Cleared on May 14, 1999 as substantially equivalent to P830037 (Alcon Laboratories, Inc., 1984) after a 10-day review. Its family tree reaches back 1 generation to 1984.

Decided: May 14, 1999
Review: 10 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P830037 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backP830037 Durasoft (R) 3 for Ext WearAlcon Laboratories, Inc. · 1984 · Recalled
This deviceK991550 Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical…Wesley Jessen Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P830037	Durasoft (R) 3 for Ext Wear	Alcon Laboratories, Inc.	1984	2
0 (this device)	K991550	Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint…	Wesley Jessen Corp.	1999	—

FIG. 1 — Lineage of K991550, 1984–1999Source: 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 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

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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	Applicant	Decided	Recalls
*	P830037	Durasoft (R) 3 for Ext Wear Summary page 3 …ibility* (Dk/L) 20 x 10° mi O, cm / sec mi mmHg *DK/L = 20 x 10 ml Oz cm / sec ml mmHg at 35°C (Dr. Irving Fatt Method) 1. “~ Reference PMA Supplement P830037/S042 Exhibit V-1, Bxhibit V-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table…	Alcon Laboratories, Inc.	1984	2

Also cleared against P830037: 4 other devices →

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 a recall.
4 other devices also cite its predicate P830037.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

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

Recalls per year · LPL

1in 2025

2007high 11 (2017) · low 0 (2008)2026

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

Adverse event reports per year · LPL

216in 2025

2007high 377 (2011) · low 110 (2021)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?

FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity and presbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfere with visual acuity. The lenses may be prescribed for Daily Wear in aphakic or not aphakic persons. The eye care practitioner…

Read the full statement (128 words)

The lenses may be prescribed for Daily Wear in aphakic or not aphakic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system.

FreshLook Lenses with UV-absorbing monomer help protect against transmission of harmful UV radiation to the cornea and into the eye.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K991550 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991550: Freshlook Bifocal UV-Absorbing (Phemfilcon a) Molded Spherical Handling Tint and Colored Soft (HYDROPHILIC0 Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991550

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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