FDA product code · Ophthalmic · Class 2
LPN: Accessories, Soft Lens Products
LPN is FDA's product code for "Accessories, Soft Lens Products": a Class 2 device classified under 21 CFR 886.5928, reviewed by the Ophthalmic panel.
510(k) review time for LPN
Across 10 510(k) clearances under LPN decided from 2018-01-01 to 2026-10-06, the median was 155 days from FDA receipt to decision. Half took between 114 and 217 days, and 80% were decided within 235 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 114 |
| Median | 155 |
| 75th percentile | 217 |
| 80th percentile | 235 |
| 90th percentile | 243 |
| Slowest | 258 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LPN in the public FDA record
| 510(k) clearances, all years | 121 |
|---|---|
| Device recalls | 23 |
| Establishment listings | 108 |
Counts of records, not of devices or events. Adverse event reports for LPN are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LPN
9 FDA recognized consensus standards cite LPN, 2 of them recognized only in part, among them ISO 18259 First Edition 2014-10-01; ANSI Z80.18-2016 (R2021); ISO 11981 Third edition 2017-11. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 10-100 ISO 18259 First Edition 2014-10-01 — Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case challenged with bacterial and fungal organisms
- 10-103 ANSI Z80.18-2016 (R2021) — American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary Performance Specifications and Test Methodology
- 10-111 ISO 11981 Third edition 2017-11 — Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
- 10-112 ISO 11986 Third edition 2017-11 — Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
- 10-141 ISO 11978 Third edition 2017-08 [Including AMD1:2020] — Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)]
- 10-77 ISO 9394 Third edition 2012-10-01 — Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
- 10-85 ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 (partial recognition) — Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
- 10-86 ISO 14729 First edition 2001-04-15 (partial recognition) — Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
- 10-99 ISO 4311 First edition 1979-06-01 — Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate stirrup or ring
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.