Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)
FDA 510(k) K091246 · Trumpf Medizin Systeme GmbH + Co. KG
510(k) numberK091246
Submission
- Device name
- Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)
- Applicant
- Trumpf Medizin Systeme GmbH + Co. KG
Charleston, SC, US - Received
- April 27, 2009
- Decision date
- September 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FSS – Light, Surgical, Floor Standing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003489 | Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next…FSS · Traditional | Medical Illumination International, Inc. | 02/02/2001SE |
| K984124 | Aesculap Xenon Light SourceFSS · Traditional | Aesculap, Inc. | 02/01/1999SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | Cuda Products Co. | 08/18/1998SE |
| K981821 | Ves 3001/2 Dual Output Video IlluminatorFSS · Traditional | Angiolaz, Inc. | 07/29/1998SE |
| K981469 | CERMAX300 LightsourceFSS · Traditional | Cuda Products Co. | 07/09/1998SE |
| K980044 | Xenon 300MXFSS · Traditional | Perkinelmer Optoelectronics | 04/03/1998SE |
| K970886 | Hanaulux Blue 80 HospitalFSS · Traditional | Heraeus Med GmbH | 04/16/1997SE |
| K961971 | Q-5000FSS · Traditional | Stryker Endoscopy | 06/28/1996SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | Cuda Products Co. | 04/30/1996SE |
| K930711 | Tri*StarFSS · Traditional | Light Technology Systems | 07/30/1993SE |
Questions and answers
When was Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M) cleared by the FDA?
Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M) (K091246) received a 510(k) decision of Substantially Equivalent on September 28, 2009, 154 days after the submission was received.
What is the product code of K091246?
The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.