FGX International Inc.
Smithfield, RI, US
FGX International Inc. appears in FDA device records in Smithfield, RI. FDA records list 8 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to FGX International Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Magnivision, Inc.510(k), recall
510(k) clearance history
FDA records hold 8 510(k) clearances for FGX International Inc. between 1987 and 1990. The busiest year on record is 1990, with 4. The most recent is 1990, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1989 | 2 |
| 1990 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K900778 | ITEM #272 MAGNIF-EYES CONTACT LENS CASE | LRX | Substantially Equivalent | |
| K900777 | ITEM #273 CONTACT LENS CASES | LRX | Substantially Equivalent | |
| K897085 | COMFEES(R) + CON-PAK(TM) LENS CASE | LRX | Substantially Equivalent | |
| K897084 | CONFEES(R)+ CONTACT LENS HOLDER | LRX | Substantially Equivalent | |
| K890533 | ITEM #352/#CS352* CONTACT LENS CASES | LRX | Substantially Equivalent | |
| K882384 | DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 | LRX | Substantially Equivalent | |
| K872567 | SOFT CONTACT LENS REMOVER | KYE | Substantially Equivalent | |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | KYE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222812 | 1000120742 | FGX INTERNATIONAL INC. | 500 George Washington Hwy, SMITHFIELD, RI 02917 US | 2026 | No device listings on this registration |
| 3007036468 | 3007036468 | FGX International Inc. | 1 W 37th St Fl 4, New York, NY 10018 US | 2026 | No device listings on this registration |
| 3010915664 | 3010915664 | FGX International Inc. | 1784 E. Main Street, Greenwood, IN 46143 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0541-04 | Product is Magnivision UltraLights reading glasses which have the dioptic power on the label and ''MAGNIVISION AN AMERICAN GREETINGS COMPANY Miramar, FL 33025'' | Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain