FTD — Lamp, Surgical Class II
FDA Device Classification
Classification Details
- Product Code
- FTD
- 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 |
|---|
| K133425 | engineered medical solutions co | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL | December 5, 2013 |
| K130513 | maquet | VOLISTA 400; VOLISTA 600 | May 8, 2013 |
| K123776 | drager medical | POLARIS 100/200 | March 8, 2013 |
| K111020 | atricure | ATRICURE DISSECTOR | June 9, 2011 |
| K100234 | hillusa | HM-LAMP II | July 8, 2010 |
| K100884 | howmedica osteonics | STRYKER KNIFELIGHT | June 25, 2010 |
| K071180 | engineered medical solutions co | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | June 20, 2007 |
| K053364 | waldmann lighting | HALUX IRIS EXAMINATION AND SURGICAL LAMP | February 23, 2006 |
| K041681 | atricure | ATRICURE DISSECTOR | July 1, 2004 |
| K013242 | steris corporation | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | December 13, 2001 |
| K010724 | drager medizintechnik | SOLA 700,SOLA 500, SOLA 300 | June 7, 2001 |
| K003423 | st. francis medical equipment co | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | February 22, 2001 |
| K981717 | stryker instruments | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | June 30, 1998 |
| K961122 | stryker instruments | STRYKER KNIFELIGHT | August 22, 1996 |
| K954263 | ophthalmic technologies | XE-LITE | October 18, 1995 |
| K942553 | burton medical products | GENESIS | June 23, 1994 |
| K931675 | medline industries | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | February 22, 1994 |
| K932451 | heraeus instruments | HANAULUX 2005 SURGICAL LIGHT | November 12, 1993 |
| K930897 | medical illumination | MI-15 EXAM SURGICAL LIGHT | June 25, 1993 |
| K895715 | w.c. heraeus | HANAULUX(R) 2000 | October 13, 1989 |