Panels › General, Plastic Surgery › Product code FSP · Class 1
Loupe, Diagnostic/Surgical
Regulation 878.4800
0510(k)s in 12 months (4 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FSP
| Company | 510(k)s | Recalls |
|---|---|---|
| Luxtec Corp. | 2 | 0 |
| Orascoptic Surgical Acuity | 0 | 2 |
| Keeler Instruments, Inc. | 1 | 0 |
| Kerr Corporation | 0 | 1 |
| Zinnanti Surgical Instruments, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 15, 1989 | K895248 | IMS5000 ILLUMINATED LOUPES Luxtec Corp. | FSP |
| Apr 12, 1989 | K891895 | SURGICAL LOUPES Zinnanti Surgical Instruments, Inc. | FSP |
| Nov 17, 1986 | K864386 | LUXTEC LOUPES FOR SURGICAL VISION Luxtec Corp. | FSP |
| May 23, 1986 | K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE Keeler Instruments, Inc. | FSP |
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