Laser Peripherals LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
12
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2073-2014Class IILP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrumenJune 20, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K170366Laser Peripherals, LLC Family of Bare Laser FibersJune 8, 2017
K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100April 25, 2003
K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBERJuly 24, 2001
K992083SCATTERFREE LATERAL EMITTING FIBERJuly 12, 1999
K974229LS-905 FIBERCHOICE ADAPTER SYSTEMFebruary 10, 1998
K972272LASER PERIPHERALS HOLMIUM BARE FIBERSJuly 29, 1997
K961516LASER PERIPHERALS INC. BARE FIBERJune 27, 1996
K961079LASER PERIPHERALS INC. SCATTERFREE FIBERMay 22, 1996
K901786LASEGUIDE CAT # CLF-600D & CLF-1000DJune 27, 1990
K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USEJune 1, 1988
K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USEApril 25, 1988
K874680LASEGUIDE 600A, 600B, 400A, AND 400BMarch 23, 1988