LPNClass II

Accessories, Soft Lens Products

21 CFR 886.5928 / Ophthalmic

LPN is the FDA product code for Accessories, Soft Lens Products, a class II device type, regulated under 21 CFR 886.5928. As of 2026-09-10, FDA records hold 121 510(k) clearances under this code, the most recent dated 2026-08-13, and 23 recalls.

Classification record

Product code: LPN
Device name: Accessories, Soft Lens Products
Regulation: 21 CFR 886.5928
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 121
Ingested recalls: 23

Clearances, product code LPN

By decision year

121 clearances under product code LPN with a decision year between 1985 and 2026, 1998 the highest year at 19.

Show the numbers

510(k) clearances under FDA product code LPN by decision year
Year	Clearances
1985	1
1986	2
1987	9
1988	2
1989	1
1992	3
1997	2
1998	19
1999	10
2000	9
2001	8
2002	4
2003	11
2004	3
2005	5
2006	2
2007	4
2009	1
2010	2
2011	3
2012	2
2013	2
2015	2
2016	3
2017	1
2019	2
2020	3
2021	2
2022	2
2026	1

Applicants with the most clearances

Product code LPN

Applicants holding the most 510(k) clearances under product code LPN
Applicant	Clearances
Alcon Laboratories	31
Bausch & Lomb Incorporated	20
Allergan	12
Advanced Medical Optics, Inc.	4
Polymer Technology Corp.	4
Sauflon Pharmaceuticals, Ltd.	4
Alcon Universal, Ltd.	3
Alcon, Inc.	3
Menicon Co. Ltd.	3
Optics Laboratory, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order