510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FCTClass II

Headlight, Fiberoptic Focusing

21 CFR 886.4335 / Ophthalmic
FDA source (opens on fda.gov)

FCT is the FDA product code for Headlight, Fiberoptic Focusing, a class II device type, regulated under 21 CFR 886.4335. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCT
Device name
Headlight, Fiberoptic Focusing
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code FCT

By decision year
6 clearances under product code FCT with a decision year between 1978 and 1996, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FCT by decision year
YearClearances
19781
19802
19881
19921
19961

Applicants with the most clearances

Product code FCT
Applicants holding the most 510(k) clearances under product code FCT
ApplicantClearances
Aspen Laboratories, Inc.2
Cameron-Miller, Inc.1
Chiron Vision Corp.1
Scieran Technologies, Inc.1
Site Microsurgical Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order