FSP · Class I · 21 CFR 878.4800

FDA Product Code FSP: Loupe, Diagnostic/surgical

Leading manufacturers include Luxtec Corp., Keeler Instruments, Inc. and Zinnanti Surgical Instruments, Inc..

4
Total
4
Cleared
18d
Avg days
1986
Since

FDA 510(k) Cleared Loupe, Diagnostic/surgical Devices (Product Code FSP)

4 devices
1–4 of 4
Cleared Sep 15, 1989
IMS5000 ILLUMINATED LOUPES
K895248
Luxtec Corp.
General & Plastic Surgery · 25d
Cleared Apr 12, 1989
SURGICAL LOUPES
K891895
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 19d
Cleared Nov 17, 1986
LUXTEC LOUPES FOR SURGICAL VISION
K864386
Luxtec Corp.
General & Plastic Surgery · 12d
Cleared May 23, 1986
3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE
K861749
Keeler Instruments, Inc.
General & Plastic Surgery · 17d

About Product Code FSP - Regulatory Context