Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST
FDA 510(k) K093386 · Bfw, Inc.
510(k) numberK093386
Submission
- Device name
- Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST
- Applicant
- Bfw, Inc.
Louisville, KY, US - Received
- October 30, 2009
- Decision date
- January 28, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code FST
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K090070 | Invuity Britefield Mcculloch Retractor SystemFST · Traditional | Invuity, Inc. | 04/22/2009SE |
Questions and answers
When was Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST cleared by the FDA?
Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FST (K093386) received a 510(k) decision of Substantially Equivalent on January 28, 2010, 90 days after the submission was received.
What is the product code of K093386?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.