Vida LED Surgical Lighting System
FDA 510(k) K132307 · Convida Healthcare & Systems Corporation
510(k) numberK132307
Submission
- Device name
- Vida LED Surgical Lighting System
- Applicant
- Convida Healthcare & Systems Corporation
Taoyuan County, TW - Received
- July 24, 2013
- Decision date
- November 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FSY – Light, Surgical, Ceiling Mounted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142984 | Leo MinorFSY · Traditional | Sunnex, Inc. | 10/29/2014SE |
| K142076 | Claveguard Freedom Surgical LightFSY · Traditional | Dickson & Dickson Healthcare (Us), Inc. | 09/30/2014SE |
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | Medical Illumination International, Inc. | 08/07/2014SE |
| K132551 | ZF 720FSY · Traditional | Umbel Corporation | 06/30/2014SE |
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | Convida Healthcare & Systems Corporation | 06/09/2014SE |
| K140461 | Mach LED 2MCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K140460 | Mach LED 2SCFSY · Special | Dr. Mach GmbH & Co. KG | 04/03/2014SE |
| K132747 | Visum Blade LED Surgical Lighting SystemFSY · Traditional | Stryker Communications | 12/30/2013SE |
| K131893 | Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional | Ajw Technology Consultants, Inc. | 10/30/2013SE |
| K122875 | Oricare L2700FSY · Traditional | Oricare, Inc. | 12/18/2012SE |
More from Oricare, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K140930 | Vida LED Surgical Lighting System, V SeriesFSY · Traditional | 06/09/2014SE |
Questions and answers
When was Vida LED Surgical Lighting System cleared by the FDA?
Vida LED Surgical Lighting System (K132307) received a 510(k) decision of Substantially Equivalent on November 5, 2013, 104 days after the submission was received.
What is the product code of K132307?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.