FDA product code LPL: Lenses, Soft Contact, Daily Wear

LPL is the FDA product code for lenses, soft contact, daily wear. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel. FDA has cleared 487 510(k) submissions under LPL, 51 in the last five years, from 143 different applicants. The average 510(k) review took 116 days (median 84); 156 days on average over the last three years. 70 PMA applications cite this product code. FDA has posted 70 recalls for LPL devices, 5 initiated in the last five years.

Classification

Field	Value
Device name	Lenses, Soft Contact, Daily Wear
Device class	Class II
Regulation	21 CFR 886.5925
Review panel	OP — Ophthalmic
Medical specialty	Ophthalmic
Premarket route	510(k)
Third-party 510(k) review eligible	Yes

510(k) clearances per year for LPL

Year	Clearances	Avg. review days
2017	9	115
2018	21	72
2019	11	126
2020	10	155
2021	8	126
2022	9	164
2023	10	180
2024	12	160
2025	12	192
2026	8	116

Compare with all 510(k) review times · Search every LPL clearance

Top LPL applicants

Applicant	Clearances	Latest
CooperVision, Inc.	37	2024-01-25
Alcon Laboratories, Inc.	22	2026-02-13
Pegavision Corporation	14	2026-05-21
Unilens Corp., USA	14	2014-10-30
Ciba Vision Corporation	14	2014-01-29

138 more applicants have LPL clearances. See the full list in Caduvo.

Most recent LPL clearances

510(k)	Applicant	Device	Decision date	Review days
K262495	Menicon Co, Ltd.	Miru 1day UpSide (midafilcon A)	2026-09-17	59
K260507	INTEROJO, Inc.	Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus	2026-05-29	101
K253352	Pegavision Corporation	Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses	2026-05-21	233
K261299	Pegavision Corporation	Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses	2026-05-19	29
K253885	GEO MEDICAL CO., LTD.	PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES	2026-04-29	146

Recalls for LPL devices

70 product recalls in 39 recall events; 5 initiated in the last five years and 13 still open. Most recent: 2025-09-30.

Year	Recalls
2017	13
2018	1
2019	1
2020	8
2021	14
2022	1
2023	1
2024	1
2025	2

Frequently asked questions

What is FDA product code LPL?

LPL is the FDA product code for lenses, soft contact, daily wear. It is a Class II device, regulated under 21 CFR 886.5925 and reviewed by the Ophthalmic panel.

What device class is LPL?

Class II, regulation 21 CFR 886.5925. Typical premarket route: 510(k).

How long does a 510(k) take for product code LPL?

Across 487 cleared submissions the average was 116 days from receipt to decision (median 84).

Which companies have the most LPL clearances?

CooperVision, Inc. (37); Alcon Laboratories, Inc. (22); Pegavision Corporation (14); Unilens Corp., USA (14); Ciba Vision Corporation (14).

Have LPL devices been recalled?

Yes: 70 product recalls across 39 recall events; the most recent began 2025-09-30.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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