Fiber Optic Adjustable Headlight
FDA 510(k) K780433 · Cameron-Miller, Inc.
510(k) numberK780433
Submission
- Device name
- Fiber Optic Adjustable Headlight
- Applicant
- Cameron-Miller, Inc.
Mchenry, IL, US - Received
- March 17, 1978
- Decision date
- June 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCT – Headlight, Fiberoptic Focusing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Specialty
- Ophthalmic
Other 510(k)s with product code FCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960767 | Light CommanderFCT · Traditional | Scieran Technologies, Inc. | 08/26/1996SE |
| K924198 | Modified Site Fiber Optic ModuleFCT · Traditional | Chiron Vision Corp. | 11/23/1992SE |
| K883480 | Modified Site Fiber Optic Module for Ophthal. UseFCT · Traditional | Site Microsurgical Systems, Inc. | 08/24/1988SE |
| K802770 | Fiber Optic Headlight #60-0766766FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K802769 | Fiber Optic Headlight #60-0765FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
More from Aspen Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944775 | Electrosurgical Unit Model 26-0335GEI · Traditional | 10/11/1994SE |
| K931541 | Model 26-0375, Electrosurgical GeneratorHGI · Traditional | 06/01/1994SE |
| K931437 | Model 80-1983, Electrosurgical GeneratorHGI · Traditional | 05/27/1994SE |
| K935490 | Electrosurgical Device, Model 26-2500GEI · Traditional | 04/01/1994SE |
| K854109 | Electrosurgical Devices, 26-0330,26-335,340 & 0345GEI · Traditional | 01/24/1986SE |
| K853972 | Cameron-Miller Model 80-2701, Bipolar CoagulatorGEI · Traditional | 01/24/1986SE |
| K833449 | Hand Controlled Pencil or Switch HandGEI · Traditional | 11/29/1983SE |
| K822092 | Cameron-Miller #40-1516GEI · Traditional | 09/21/1982SE |
| K812702 | TechnicatorGEI · Traditional | 11/05/1981SE |
| K791415 | Model 80-1765 Electrosurgical UnitGEI · Traditional | 10/11/1979SE |
Questions and answers
When was Fiber Optic Adjustable Headlight cleared by the FDA?
Fiber Optic Adjustable Headlight (K780433) received a 510(k) decision of Substantially Equivalent on June 13, 1978, 88 days after the submission was received.
What is the product code of K780433?
The FDA product code is FCT – Headlight, Fiberoptic Focusing, a Class II (moderate risk) device regulated under 21 CFR 886.4335.