Company ยท US
Luxtec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1997. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | 3 |
| FCW | Light Source, Fiberoptic, Routine | 2 |
| FSP | Loupe, Diagnostic/Surgical | 2 |
| HRX | Arthroscope | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 |
| FST | Light, Surgical, Fiberoptic | 1 |
| FWC | Camera, Television, Surgical, With Audio | 1 |
| GAD | Retractor | 1 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | 1 |
| HQF | Laser, Ophthalmic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 1997 | K973193 | LUXSCOPE Luxtec Corp. | HQF |
| May 21, 1997 | K970642 | TENOSCOPE Luxtec Corp. | HRX |
| May 14, 1997 | K970562 | TENOSNARE Luxtec Corp. | HRX |
| Sep 8, 1995 | K950960 | REDDY ILLUMINATOR Luxtec Corp. | FFS |
| Sep 15, 1989 | K895248 | IMS5000 ILLUMINATED LOUPES Luxtec Corp. | FSP |
| Apr 26, 1989 | K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE Luxtec Corp. | FCW |
| May 22, 1987 | K864387 | LUXTEC FIBEROPTIC CABLES Luxtec Corp. | EQH |
| Jan 14, 1987 | K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS Luxtec Corp. | EQH |
| Jan 14, 1987 | K864382 | FRAZIER SUCTION TUBE Luxtec Corp. | EQH |
| Jan 13, 1987 | K864385 | LUXTEC LIGHT SOURCES Luxtec Corp. | FCW |
| Jan 9, 1987 | K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC Luxtec Corp. | HDG |
| Dec 9, 1986 | K864381 | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM Luxtec Corp. | FWC |
| Nov 19, 1986 | K864384 | LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS Luxtec Corp. | GAD |
| Nov 19, 1986 | K864380 | LUTEX HEADLIGHT SYSTEMS Luxtec Corp. | FST |
| Nov 17, 1986 | K864386 | LUXTEC LOUPES FOR SURGICAL VISION Luxtec Corp. | FSP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||