ILED
FDA 510(k) clearance K061317 · decided 2006-06-22
Clearance details
- K-number
- K061317
- Device name
- ILED
- Applicant
- Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg
- Decision
- Substantially Equivalent
- Date received
- 2006-05-11
- Decision date
- 2006-06-22
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FSY
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Munchen, DE
- Third-party review
- Yes
- Expedited review
- No
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| MACH LED 2SC (K140460) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| MACH LED 2MC (K140461) | Dr. Mach GmbH & Co. KG | 2014-04-03 |
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| AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (K131893) | Ajw Technology Consultants, Inc. | 2013-10-30 |
| ORICARE L2700 (K122875) | Oricare, Inc. | 2012-12-18 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMP recall (Z-2353-2015) | Trumpf Medical Systems, Inc. | 2015-08-07 |
| Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. recall (Z-2354-2015) | Trumpf Medical Systems, Inc. | 2015-08-07 |
| Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TR recall (Z-2356-2015) | Trumpf Medical Systems, Inc. | 2015-08-07 |
| Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TR recall (Z-2357-2015) | Trumpf Medical Systems, Inc. | 2015-08-07 |
| Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizins recall (Z-2311-2012) | Trumpf Medical Systems, Inc. | 2012-09-05 |
| ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K recall (Z-1122-2009) | Trumpf Medical Systems, Inc. | 2009-04-01 |