FDA product code LXS: Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
LXS is the FDA product code for laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla. It is a Class II device, regulated under 21 CFR 886.4392 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under LXS, from 5 different applicants. The average 510(k) review took 98 days (median 79). 2 PMA applications cite this product code. FDA has posted 1 recall for LXS devices.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Device class | Class II |
| Regulation | 21 CFR 886.4392 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LXS clearance
Top LXS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nidek, Inc. | 2 | 1989-08-18 |
| Meridian AG | 1 | 2002-09-26 |
| Phoenix Laser Systems, Inc. | 1 | 1990-12-13 |
| Lasag AG | 1 | 1989-12-29 |
| Intelligent Surgical Lasers, Inc. | 1 | 1989-06-15 |
Most recent LXS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023045 | Meridian AG | MICRORUPTER V | 2002-09-26 | 14 |
| K901605 | Phoenix Laser Systems, Inc. | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | 1990-12-13 | 252 |
| K895864 | Lasag AG | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | 1989-12-29 | 87 |
| K893987 | Nidek, Inc. | NIDEK MODEL YC-1200 | 1989-08-18 | 74 |
| K892204 | Nidek, Inc. | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | 1989-06-22 | 80 |
Recalls for LXS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-06.
Frequently asked questions
What is FDA product code LXS?
LXS is the FDA product code for laser, neodymium:yag, ophthalmic for posterior capsulotomy and cutting pupilla. It is a Class II device, regulated under 21 CFR 886.4392 and reviewed by the Ophthalmic panel.
What device class is LXS?
Class II, regulation 21 CFR 886.4392. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXS?
Across 6 cleared submissions the average was 98 days from receipt to decision (median 79).
Which companies have the most LXS clearances?
Nidek, Inc. (2); Meridian AG (1); Phoenix Laser Systems, Inc. (1); Lasag AG (1); Intelligent Surgical Lasers, Inc. (1).
Have LXS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LXS
- Run a recall and safety report across every LXS manufacturer
- Watch product code LXS 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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