FSY — Light, Surgical, Ceiling Mounted Class II
FDA product code FSY covers "Light, Surgical, Ceiling Mounted", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSY
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142984 | sunnex | Leo Minor | October 29, 2014 |
| K142076 | dickson and dickson healthcare (us) | CLAVEGUARD FREEDOM SURGICAL LIGHT | September 30, 2014 |
| K140812 | medical illumination international | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | August 7, 2014 |
| K132551 | umbel corporation | ZF 720 | June 30, 2014 |
| K140930 | convida healthcare and systems corporation | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | June 9, 2014 |
| K140460 | mach gmbh and co. kg | MACH LED 2SC | April 3, 2014 |
| K140461 | mach gmbh and co. kg | MACH LED 2MC | April 3, 2014 |
| K132747 | stryker communications | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | December 30, 2013 |
| K132307 | convida healthcare and systems corporation | VIDA LED SURGICAL LIGHTING SYSTEM | November 5, 2013 |
| K131893 | ajw technology consultants | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | October 30, 2013 |
| K122875 | oricare | ORICARE L2700 | December 18, 2012 |
| K120392 | berchtold gmbh and co. kg | CHROMOPHARE F 628 AND F 528 | February 16, 2012 |
| K102758 | trumpf kreuzer medizin systeme gmbh + co.kg | TRULIGHT 5520 AND TRULIGHT 5320 | October 26, 2010 |
| K101537 | burton medical products | AIM 200, MAJOR SURGICAL LIGHT | September 30, 2010 |
| K100702 | huot instruments | STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MO | July 20, 2010 |
| K093009 | mach gmbh and co. kg | MACH LED SC | April 1, 2010 |
| K093010 | mach gmbh and co. kg | MACH LED MC | April 1, 2010 |
| K090378 | berchtold gmbh and co. kg | CHROMOPHARE E 668 | February 23, 2009 |
| K083323 | nuvo | NUVO VERDE LED LIGHTING SYSTEM | January 28, 2009 |
| K083066 | berchtold holding | CHROMOPHARE E 778 AND E 558 | October 30, 2008 |