FSS — Light, Surgical, Floor Standing Class II
FDA product code FSS covers "Light, Surgical, Floor Standing", 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
- FSS
- 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 |
|---|---|---|---|
| K091246 | trumpf medizin systeme gmbh + co. kg | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M | September 28, 2009 |
| K003489 | medical illumination international | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT G | February 2, 2001 |
| K984124 | aesculap | AESCULAP XENON LIGHT SOURCE | February 1, 1999 |
| K981962 | cuda products | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | August 18, 1998 |
| K981821 | angiolaz | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | July 29, 1998 |
| K981469 | cuda products | CERMAX300 LIGHTSOURCE | July 9, 1998 |
| K980044 | perkinelmer optoelectronics | XENON 300MX | April 3, 1998 |
| K970886 | heraeus med | HANAULUX BLUE 80 HOSPITAL | April 16, 1997 |
| K961971 | stryker endoscopy | Q-5000 | June 28, 1996 |
| K961074 | cuda products | LIGHTSOURCE OR ILLUMINATOR | April 30, 1996 |
| K930711 | light technology systems | TRI*STAR | July 30, 1993 |
| K910942 | mdt biologic | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | June 11, 1991 |
| K895950 | f.w. lang | MODEL FEL5100 FLOOR LIGHT | October 31, 1989 |
| K893813 | astralite | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | July 14, 1989 |
| K891759 | kinetic biomedical services | KINETIC MODEL 330 | April 19, 1989 |
| K891758 | kinetic biomedical services | KINETIC MODEL 132 | April 19, 1989 |
| K882333 | commercial products and engineering | FLOOR LIGHT | June 23, 1988 |
| K880540 | ferguson medical | LIGHT, SURGICAL, FLOOR STANDING | February 24, 1988 |
| K880198 | american sterilizer | GEMINI SURGICAL LIGHT | February 10, 1988 |
| K860020 | adel medical | MINOR SURGERY LIGHT MODEL 2112 | January 24, 1986 |