FDA product code LWL: Fluid, Intraocular
LWL is the FDA product code for fluid, intraocular. It is a Class III device, regulated under 21 CFR 886.4275 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under LWL. The average 510(k) review took 189 days (median 189). 4 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Intraocular |
| Device class | Class III |
| Regulation | 21 CFR 886.4275 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every LWL clearance
Top LWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optical Micro Systems, Inc. | 1 | 1985-06-24 |
Most recent LWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844895 | Optical Micro Systems, Inc. | OMS SILICONE OIL INJECTOR | 1985-06-24 | 189 |
Recalls for LWL devices
openFDA lists no recalls for product code LWL.
Frequently asked questions
What is FDA product code LWL?
LWL is the FDA product code for fluid, intraocular. It is a Class III device, regulated under 21 CFR 886.4275 and reviewed by the Ophthalmic panel.
What device class is LWL?
Class III, regulation 21 CFR 886.4275. Typical premarket route: PMA.
How long does a 510(k) take for product code LWL?
Across 1 cleared submissions the average was 189 days from receipt to decision (median 189).
Which companies have the most LWL clearances?
Optical Micro Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LWL
- Run a recall and safety report across every LWL manufacturer
- Watch product code LWL 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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