FDA product code LRX: Case, Contact Lens
LRX is the FDA product code for case, contact lens. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel. FDA has cleared 82 510(k) submissions under LRX, 4 in the last five years, from 58 different applicants. The average 510(k) review took 115 days (median 74); 216 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Case, Contact Lens |
| 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 LRX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 45 |
| 2023 | 1 | 132 |
| 2024 | 1 | 271 |
| 2025 | 1 | 162 |
| 2026 | 1 | 214 |
Compare with all 510(k) review times · Search every LRX clearance
Top LRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Magnivision, Inc. | 6 | 1990-03-30 |
| Applied Laboratories, Inc. | 6 | 1988-03-24 |
| Paragon Vision Sciences | 3 | 1999-12-22 |
| Alcon Laboratories | 3 | 1998-01-20 |
| Ryder Intl. Corp. | 3 | 1992-03-04 |
53 more applicants have LRX clearances. See the full list in Caduvo.
Most recent LRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252175 | Fourth Axis, LLC | LANDR Contact LENS Case | 2026-02-10 | 214 |
| K250495 | Avizor S.A. | MINI VP1 (PL67_F); MINI VP1 (PL61_F) | 2025-08-01 | 162 |
| K240095 | Shanghai Care US Medical Product Co., Ltd. | CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) | 2024-10-09 | 271 |
| K231123 | Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | 2023-08-30 | 132 |
| K173538 | Alcon Laboratories, Inc. | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | 2017-12-04 | 19 |
Recalls for LRX devices
openFDA lists no recalls for product code LRX.
Frequently asked questions
What is FDA product code LRX?
LRX is the FDA product code for case, contact lens. It is a Class II device, regulated under 21 CFR 886.5928 and reviewed by the Ophthalmic panel.
What device class is LRX?
Class II, regulation 21 CFR 886.5928. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRX?
Across 82 cleared submissions the average was 115 days from receipt to decision (median 74).
Which companies have the most LRX clearances?
Magnivision, Inc. (6); Applied Laboratories, Inc. (6); Paragon Vision Sciences (3); Alcon Laboratories (3); Ryder Intl. Corp. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code LRX
- Run a recall and safety report across every LRX manufacturer
- Watch product code LRX 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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