Medicam Xenon Light Source
FDA 510(k) K943342 · M.P. Video, Inc.
510(k) numberK943342
Submission
- Device name
- Medicam Xenon Light Source
- Applicant
- M.P. Video, Inc.
Medway, MA, US - Received
- July 12, 1994
- Decision date
- October 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FSW – Light, Surgical, Endoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022989 | Radlite Tissue Retractor SystemFSW · Traditional | Genzyme Biosurgery | 11/25/2002SE |
| K013511 | Xenalight Models # AX9125 (100-120V~); # AX9225 (220-240V~)FSW · Traditional | Aculux, Inc. | 02/01/2002SE |
| K934337 | Cuda Products Corp. Model MX2-300 LightsourceFSW · Traditional | Cuda Products Co. | 11/18/1993SE |
| K922279 | Illuminator IV Minor Surgery LightFSW · Traditional | Medical Illumination, Inc. | 09/02/1992SE |
| K913135 | LM-300TWINFSW · Traditional | Leisegang Medical, Inc. | 09/18/1991SE |
| K894319 | Medical Dynamics Light SourceFSW · Traditional | Medical Dynamics, Inc. | 10/03/1989SE |
| K870898 | Ultra-Lux Light SourceFSW · Traditional | Medline Industries, Inc. | 03/18/1987SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951386 | Combination Camera/Light SourceGCJ · Traditional | 06/30/1995SE |
| K942358 | Autoclaveable Medicam 900 Digicon CameraGCJ · Traditional | 08/08/1994SE |
| K941773 | Medicam 900 RemoteGCJ · Traditional | 07/18/1994SE |
| K941693 | Medicam Endocoupler and BeamsplitterGCJ · Traditional | 06/27/1994SE |
| K893828 | ML-800 Autoelectronic Light SourceFST · Traditional | 07/24/1989SE |
| K882924 | Medicam MC-7 and RP-7 Surgical CamerasKQM · Traditional | 07/26/1988SE |
| K871595 | Surgical Camera AccessoriesKQM · Traditional | 05/07/1987SE |
| K871057 | Mc-Series Surgical CamerasFWB · Traditional | 04/03/1987SE |
| K871056 | Medicam S-4 Surgical CameraFWF · Traditional | 03/31/1987SE |
| K820829 | MedicamFWB · Traditional | 05/03/1982SE |
Questions and answers
When was Medicam Xenon Light Source cleared by the FDA?
Medicam Xenon Light Source (K943342) received a 510(k) decision of Substantially Equivalent on October 17, 1994, 97 days after the submission was received.
What is the product code of K943342?
The FDA product code is FSW – Light, Surgical, Endoscopic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.