FCT · Class II · 21 CFR 886.4335

FDA Product Code FCT: Headlight, Fiberoptic Focusing

Leading manufacturers include Aspen Laboratories, Inc., Site Microsurgical Systems, Inc. and Chiron Vision Corp..

6
Total
6
Cleared
75d
Avg days
1978
Since

FDA 510(k) Cleared Headlight, Fiberoptic Focusing Devices (Product Code FCT)

6 devices
1–6 of 6
Cleared Nov 23, 1992
MODIFIED SITE FIBER OPTIC MODULE
K924198
Chiron Vision Corp.
Ophthalmic · 95d
Cleared Aug 24, 1988
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
K883480
Site Microsurgical Systems, Inc.
Ophthalmic · 8d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0765
K802769
Aspen Laboratories, Inc.
Ophthalmic · 38d
Cleared Dec 11, 1980
FIBER OPTIC HEADLIGHT #60-0766766
K802770
Aspen Laboratories, Inc.
Ophthalmic · 38d

About Product Code FCT - Regulatory Context