MI-750 Procedural/Minor Surgical Light
FDA 510(k) K140812 · Medical Illumination International, Inc.
510(k) numberK140812
Submission
- Device name
- MI-750 Procedural/Minor Surgical Light
- Applicant
- Medical Illumination International, Inc.
San Fernando, CA, US - Received
- April 1, 2014
- Decision date
- August 7, 2014
- 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 |
| 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 |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| 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 |
|---|---|---|
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | 06/22/2010SE |
| K053227 | Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights…FST · Traditional | 01/13/2006SE |
| K010495 | Centura Phototherapy SpotlightLBI · Traditional | 03/09/2001SE |
| K003489 | Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional | 02/02/2001SE |
Questions and answers
When was MI-750 Procedural/Minor Surgical Light cleared by the FDA?
MI-750 Procedural/Minor Surgical Light (K140812) received a 510(k) decision of Substantially Equivalent on August 7, 2014, 128 days after the submission was received.
What is the product code of K140812?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.