FDA product code · Ophthalmic · Class 2
LPL: Lenses, Soft Contact, Daily Wear
LPL is FDA's product code for "Lenses, Soft Contact, Daily Wear": a Class 2 device classified under 21 CFR 886.5925, reviewed by the Ophthalmic panel.
510(k) review time for LPL
Across 101 510(k) clearances under LPL decided from 2018-01-01 to 2026-10-06, the median was 115 days from FDA receipt to decision. Half took between 54 and 225 days, and 80% were decided within 233 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 54 |
| Median | 115 |
| 75th percentile | 225 |
| 80th percentile | 233 |
| 90th percentile | 260 |
| Slowest | 459 |
| Year | Median days | n |
|---|---|---|
| 2018 | 56 | 21 |
| 2019 | 115 | 11 |
| 2020 | 158 | 10 |
| 2021 | 88 | 8 |
| 2022 | 212 | 9 |
| 2023 | 167 | 10 |
| 2024 | 128 | 12 |
| 2025 | 202 | 12 |
| 2026 (to 10-06, partial) | 90 | 8 |
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.
LPL in the public FDA record
| 510(k) clearances, all years | 486 |
|---|---|
| Device recalls | 70 |
| Establishment listings | 1,005 |
| GUDID device identifiers | 10,572 |
Counts of records, not of devices or events. Adverse event reports for LPL 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 LPL
14 FDA recognized consensus standards cite LPL, 3 of them recognized only in part, among them ISO 18259 First Edition 2014-10-01; ISO 18189 First edition 2016-06-01; ANSI Z80.20-2016 (R2021). 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
- 10-101 ISO 18189 First edition 2016-06-01 — Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
- 10-104 ANSI Z80.20-2016 (R2021) (partial recognition) — American National Standard for Ophthalmics - Contact Lenses - Standard Terminology Tolerances Measurements and Physicochemical Properties
- 10-106 ISO 18369-3 Second edition 2017-08 — Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
- 10-107 ISO 18369-4 Second edition 2017-08 — Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
- 10-108 ISO 18369-2 Third edition 2017-08 (partial recognition) — Ophthalmic optics - Contact lenses - Part 2: Tolerances
- 10-109 ISO 18369-1 Second edition 2017-08 — Ophthalmic optics - Contact lenses - Part 1: Vocabulary classification system and recommendations for labelling specifications
- 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
- 10-128 ASTM D882-18 — Standard Test Methods for Tensile Properties of Thin Plastic Sheeting
- 10-139 ISO 11980 Fourth edition 2025-06 — Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
- 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.