Surgical Headlight
FDA 510(k) K061690 · Gulf Medical Fiberoptics
510(k) numberK061690
Submission
- Device name
- Surgical Headlight
- Applicant
- Gulf Medical Fiberoptics
Oldsmar, FL, US - Received
- June 15, 2006
- Decision date
- September 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With…FST · Traditional | Innovasis, Inc. | 06/30/2020SE |
| K141330 | Endo-CordFST · Traditional | Enroxtech, Inc. | 12/15/2014SE |
| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | Stryker Spine | 11/01/2012SE |
| K113697 | Eigr Surgical Illumination SystemFST · Special | Invuity, Inc. | 02/10/2012SE |
| K113330 | CablecapFST · Traditional | Sensormed | 01/12/2012SE |
| K102266 | Isoled Ac-Powered LED Headlight SystemFST · Traditional | Isolux, LLC | 09/24/2010SE |
| K101496 | Cablecap Model: WLF, STZ, AcmFST · Traditional | Sensormed | 09/14/2010SE |
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | Medical Illumination International, Inc. | 06/22/2010SE |
| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
| K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTFST · Traditional | Bfw, Inc. | 01/28/2010SE |
More from Bfw, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021931 | Endoscopic Fiberoptic CableHBI · Traditional | 09/06/2002SE |
Questions and answers
When was Surgical Headlight cleared by the FDA?
Surgical Headlight (K061690) received a 510(k) decision of Substantially Equivalent on September 15, 2006, 92 days after the submission was received.
What is the product code of K061690?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.