Luxtec Aco Series 4000 Light Source
FDA 510(k) K890716 · Luxtec Corp.
510(k) numberK890716
Submission
- Device name
- Luxtec Aco Series 4000 Light Source
- Applicant
- Luxtec Corp.
Sturbridge, MA, US - Received
- February 13, 1989
- Decision date
- April 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCW – Light Source, Fiberoptic, Routine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131226 | Novaprobe LED Light SourceFCW · Traditional | Novaprobe Incorporated | 07/24/2014SE |
| K123956 | Power LED 175FCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/25/2013SE |
| K123359 | OVS1 Video SystemFCW · Traditional | Olive Medical Corp. | 12/19/2012SE |
| K121724 | Endolight LED 1.1 Endolightled 1.2FCW · Traditional | Richard Wolf Medical Instruments Corp. | 09/20/2012SE |
| K093792 | LED Light SourceFCW · Traditional | Sunoptic Technologies, LLC | 03/18/2010SE |
| K091968 | Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020CFCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/14/2009SE |
| K082813 | Stryker LED LightsourceFCW · Traditional | Stryker Corp. | 12/19/2008SE |
| K081477 | Luxtec MLX Light SourceFCW · Traditional | Integra Luxtec, Inc. | 06/18/2008SE |
| K032430 | Acueity Medical Light SourceFCW · Traditional | Acueity, Inc. | 09/05/2003SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | Circon Video | 10/17/2001SE |
More from Circon Video
| 510(k) | Device | Decision |
|---|---|---|
| K973193 | LuxscopeHQF · Traditional | 11/21/1997SE |
| K970642 | TenoscopeHRX · Traditional | 05/21/1997SE |
| K970562 | TenosnareHRX · Traditional | 05/14/1997SE |
| K950960 | Reddy IlluminatorFFS · Traditional | 09/08/1995SE |
| K895248 | IMS5000 Illuminated LoupesFSP · Traditional | 09/15/1989SE |
| K864387 | Luxtec Fiberoptic CablesEQH · Traditional | 05/22/1987SE |
| K864383 | Luxtec, Killian and Vienna Nasal SpeculumsEQH · Traditional | 01/14/1987SE |
| K864382 | Frazier Suction TubeEQH · Traditional | 01/14/1987SE |
| K864385 | Luxtec Light SourcesFCW · Traditional | 01/13/1987SE |
| K864865 | Speculum, Vaginal, Metal FiberopticHDG · Traditional | 01/09/1987SE |
Questions and answers
When was Luxtec Aco Series 4000 Light Source cleared by the FDA?
Luxtec Aco Series 4000 Light Source (K890716) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 72 days after the submission was received.
What is the product code of K890716?
The FDA product code is FCW – Light Source, Fiberoptic, Routine, a Class II (moderate risk) device regulated under 21 CFR 876.1500.