Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8
FDA 510(k) K003489 · Medical Illumination International, Inc.
510(k) numberK003489
Submission
- Device name
- Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8
- Applicant
- Medical Illumination International, Inc.
San Fernando, CA, US - Received
- November 13, 2000
- Decision date
- February 2, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated | Trumpf Medizin Systeme GmbH + Co. KG | 09/28/2009SE |
| 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 |
More from Light Technology Systems
| 510(k) | Device | Decision |
|---|---|---|
| K140812 | MI-750 Procedural/Minor Surgical LightFSY · Traditional | 08/07/2014SE |
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | 06/22/2010SE |
| K053227 | Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights…FST · Traditional | 01/13/2006SE |
| K010495 | Centura Phototherapy SpotlightLBI · Traditional | 03/09/2001SE |
Questions and answers
When was Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 cleared by the FDA?
Next General M20 Surgical Light; Next Generation M16 Minor Surgery Light; Next Generation Spotlight; Next Generation M8 (K003489) received a 510(k) decision of Substantially Equivalent on February 2, 2001, 81 days after the submission was received.
What is the product code of K003489?
The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.