FDA product code LPN: Accessories, Soft Lens Products
LPN is the FDA product code for accessories, soft lens products. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel. FDA has cleared 121 510(k) submissions under LPN, 3 in the last five years, from 47 different applicants. The average 510(k) review took 130 days (median 90); 258 days on average over the last three years. 98 PMA applications cite this product code. FDA has posted 23 recalls for LPN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Soft Lens Products |
| Device class | Class II |
| Regulation | 21 CFR 886.5928 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LPN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 54 |
| 2019 | 2 | 87 |
| 2020 | 3 | 151 |
| 2021 | 2 | 190 |
| 2022 | 2 | 134 |
| 2026 | 1 | 258 |
Compare with all 510(k) review times · Search every LPN clearance
Top LPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bausch & Lomb, Inc. | 15 | 2012-04-30 |
| Ciba Vision Corporation | 14 | 2005-08-10 |
| Allergan, Inc. | 12 | 2019-08-08 |
| Alcon Laboratories | 12 | 1999-09-16 |
| Bausch & Lomb, Incorporated | 5 | 2022-12-06 |
42 more applicants have LPN clearances. See the full list in Caduvo.
Most recent LPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253795 | Menicon Co, Ltd. | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | 2026-08-13 | 258 |
| K222541 | Bausch & Lomb, Incorporated | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | 2022-12-06 | 106 |
| K221263 | Chemtex USA, Inc. | Aqua Naina Plus Sterile Saline Solution | 2022-10-12 | 163 |
| K202932 | Bausch & Lomb, Incorporated | ABT12 multi-purpose solution | 2021-05-28 | 241 |
| K210051 | Ote North America, LLC | OTE MPS 045 Multi-purpose Lens Care Solution | 2021-05-26 | 138 |
Recalls for LPN devices
23 product recalls in 15 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2022-06-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 4 |
Frequently asked questions
What is FDA product code LPN?
LPN is the FDA product code for accessories, soft lens products. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel.
What device class is LPN?
Class II, regulation 21 CFR 886.5928. Typical premarket route: 510(k).
How long does a 510(k) take for product code LPN?
Across 121 cleared submissions the average was 130 days from receipt to decision (median 90).
Which companies have the most LPN clearances?
Bausch & Lomb, Inc. (15); Ciba Vision Corporation (14); Allergan, Inc. (12); Alcon Laboratories (12); Bausch & Lomb, Incorporated (5).
Have LPN devices been recalled?
Yes: 23 product recalls across 15 recall events; the most recent began 2022-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code LPN
- Run a recall and safety report across every LPN manufacturer
- Watch product code LPN for new clearances and recalls
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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