Product code LWL— Ophthalmic
OMS SILICONE OIL INJECTOR
- Classification name
- Fluid, Intraocular
- Device class
- Class 3
- Regulation
- 21 CFR 886.4275
- Advisory panel
- Ophthalmic
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LWL
FDA has cleared device under product code LWL, all in 1985, filed by 1 applicant company. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Top applicants under product code LWL
Adverse events under product code LWL
product code LWL- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code LWL
Data sourced from openFDA. This site is unofficial and independent of the FDA.