Product code FSP— General, Plastic Surgery

FDA has cleared 4 devices under product code FSP between 1986 and 1989, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19892 clearances
• 19862 clearances

• Luxtec Corp.2 clearances
• Zinnanti Surgical Instruments, Inc.1 clearance
• Keeler Instruments, Inc.1 clearance

• K895248 — IMS5000 ILLUMINATED LOUPESLuxtec Corp.·1989-09-15
• K891895 — SURGICAL LOUPESZinnanti Surgical Instruments, Inc.·1989-04-12
• K864386 — LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.·1986-11-17
• K861749 — 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCEKeeler Instruments, Inc.·1986-05-23