Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical Lights
FDA 510(k) K131893 · Ajw Technology Consultants, Inc.
510(k) numberK131893
Submission
- Device name
- Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical Lights
- Applicant
- Ajw Technology Consultants, Inc.
Apollo Beach, FL, US - Received
- June 25, 2013
- Decision date
- October 30, 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 |
| K132307 | Vida LED Surgical Lighting SystemFSY · Traditional | Convida Healthcare & Systems Corporation | 11/05/2013SE |
| K122875 | Oricare L2700FSY · Traditional | Oricare, Inc. | 12/18/2012SE |
More from Oricare, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141104 | Truklear BracketNJM · Special | 06/25/2014SE |
Questions and answers
When was Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical Lights cleared by the FDA?
Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical Lights (K131893) received a 510(k) decision of Substantially Equivalent on October 30, 2013, 127 days after the submission was received.
What is the product code of K131893?
The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.