FDA product code LXP: Plug, Scleral
LXP is the FDA product code for plug, scleral. It is a Class II device, regulated under 21 CFR 886.4155 and reviewed by the Ophthalmic panel. FDA has cleared 10 510(k) submissions under LXP, from 8 different applicants. The average 510(k) review took 119 days (median 92).
Definition
Intended to provide temporary closure of a scleral incision during an ophthalmic procedure.
Classification
| Field | Value |
|---|---|
| Device name | Plug, Scleral |
| Device class | Class II |
| Regulation | 21 CFR 886.4155 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LXP clearance
Top LXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Surgical Products, Inc. | 3 | 1988-05-13 |
| Microvision, Inc. | 1 | 2003-02-26 |
| Ophthalmic Consultants, Inc. | 1 | 1999-07-13 |
| Visitec Co. | 1 | 1995-02-23 |
| O.R. Specialties, Inc. | 1 | 1993-08-02 |
3 more applicants have LXP clearances. See the full list in Caduvo.
Most recent LXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022186 | Microvision, Inc. | SCLERAL PLUGS, 19 AND 20 GAUGE | 2003-02-26 | 236 |
| K990872 | Ophthalmic Consultants, Inc. | SCLERAL PLUGS, 19 AND 20 GAUGE | 1999-07-13 | 119 |
| K945114 | Visitec Co. | VISITEC SCLERAL PLUG | 1995-02-23 | 128 |
| K925671 | O.R. Specialties, Inc. | DISPOSABLE SCLERAL PLUGS | 1993-08-02 | 265 |
| K880952 | Advanced Surgical Products, Inc. | PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS | 1988-05-13 | 67 |
Recalls for LXP devices
openFDA lists no recalls for product code LXP.
Frequently asked questions
What is FDA product code LXP?
LXP is the FDA product code for plug, scleral. It is a Class II device, regulated under 21 CFR 886.4155 and reviewed by the Ophthalmic panel.
What device class is LXP?
Class II, regulation 21 CFR 886.4155. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXP?
Across 10 cleared submissions the average was 119 days from receipt to decision (median 92).
Which companies have the most LXP clearances?
Advanced Surgical Products, Inc. (3); Microvision, Inc. (1); Ophthalmic Consultants, Inc. (1); Visitec Co. (1); O.R. Specialties, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXP
- Run a recall and safety report across every LXP manufacturer
- Watch product code LXP 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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