FDA product code FCT: Headlight, Fiberoptic Focusing
FCT is the FDA product code for headlight, fiberoptic focusing. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under FCT, from 5 different applicants. The average 510(k) review took 75 days (median 63).
Classification
| Field | Value |
|---|---|
| Device name | Headlight, Fiberoptic Focusing |
| Device class | Class II |
| Regulation | 21 CFR 886.4335 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FCT clearance
Top FCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aspen Laboratories, Inc. | 2 | 1980-12-11 |
| Scieran Technologies, Inc. | 1 | 1996-08-26 |
| Chiron Vision Corp. | 1 | 1992-11-23 |
| Site Microsurgical Systems, Inc. | 1 | 1988-08-24 |
| Cameron-Miller, Inc. | 1 | 1978-06-13 |
Most recent FCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960767 | Scieran Technologies, Inc. | LIGHT COMMANDER | 1996-08-26 | 182 |
| K924198 | Chiron Vision Corp. | MODIFIED SITE FIBER OPTIC MODULE | 1992-11-23 | 95 |
| K883480 | Site Microsurgical Systems, Inc. | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | 1988-08-24 | 8 |
| K802769 | Aspen Laboratories, Inc. | FIBER OPTIC HEADLIGHT #60-0765 | 1980-12-11 | 38 |
| K802770 | Aspen Laboratories, Inc. | FIBER OPTIC HEADLIGHT #60-0766766 | 1980-12-11 | 38 |
Recalls for FCT devices
openFDA lists no recalls for product code FCT.
Frequently asked questions
What is FDA product code FCT?
FCT is the FDA product code for headlight, fiberoptic focusing. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel.
What device class is FCT?
Class II, regulation 21 CFR 886.4335. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCT?
Across 6 cleared submissions the average was 75 days from receipt to decision (median 63).
Which companies have the most FCT clearances?
Aspen Laboratories, Inc. (2); Scieran Technologies, Inc. (1); Chiron Vision Corp. (1); Site Microsurgical Systems, Inc. (1); Cameron-Miller, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCT
- Run a recall and safety report across every FCT manufacturer
- Watch product code FCT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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