510(k) K864380 ยท FST Light, Surgical, Fiberoptic
LUTEX HEADLIGHT SYSTEMS
| Applicant | Luxtec Corp., Sturbridge MA, US |
| Decision | Substantially Equivalent, Nov 19, 1986 |
| Received | Nov 5, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Pro Headlight with 9ft bifurcated cable
Model: AX2000BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for s Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System with 9ft premium bifurcated cable
Model: AX2100BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System Headband
Model: AXI375BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System with short linkage
Model: AX 1375BIFSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for s Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System sweatband
Model: AXI385BIF
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Luxtec UltraLite Headlight System sweatband with short linkage
Model: AXI385BIFSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sou Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. Mark II Headlight module-black with short linkage
Model: 001380LXSL
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgi Terminated |
FST | None listed |
| Jan 11, 2012 | Integra LifeSciences Corp. UltraLite Headlight module-grey
Model: 001328
Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination. Terminated |
FST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.