Light, Surgical, Floor Standing
FDA product code FSS · Class II (moderate risk) · 21 CFR 878.4580 · General, Plastic Surgery
20510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Cuda Products Co. 3
- Kinetic Biomedical Services, Inc. 2
- Light Technology Systems 1
- Trumpf Medizin Systeme GmbH + Co. KG 1
- Medical Illumination International, Inc. 1
- Aesculap, Inc. 1
- Angiolaz, Inc. 1
- Perkinelmer Optoelectronics 1
- Heraeus Med GmbH 1
- Stryker Endoscopy 1
- Adel Medical , Ltd. 1
- Mdt Biologic Co. 1
- F.W. Lang Co. 1
- Astralite Corp. 1
- Commercial Products & Engineering Co. 1
- Ferguson Medical 1
- American Sterilizer Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091246 | Iled 3 Mobile (I300M), Trulight 5500 Mobile (T500M), Trulight 5300 Mobile (T300M)FSS · Abbreviated | Trumpf Medizin Systeme GmbH + Co. KG | 09/28/2009SE |
| 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 |
| K910942 | Ac Powered and Battery Powered Medical Exam. LightFSS · Traditional | Mdt Biologic Co. | 06/11/1991SE |
| K895950 | Model FEL5100 Floor LightFSS · Traditional | F.W. Lang Co. | 10/31/1989SE |
| K893813 | Floor Standing, Operating and Examining LightFSS · Traditional | Astralite Corp. | 07/14/1989SE |
| K891759 | Kinetic Model 330FSS · Traditional | Kinetic Biomedical Services, Inc. | 04/19/1989SE |
| K891758 | Kinetic Model 132FSS · Traditional | Kinetic Biomedical Services, Inc. | 04/19/1989SE |
| K882333 | Floor LightFSS · Traditional | Commercial Products & Engineering Co. | 06/23/1988SE |
| K880540 | Light, Surgical, Floor StandingFSS · Traditional | Ferguson Medical | 02/24/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | American Sterilizer Co. | 02/10/1988SE |
| K860020 | Minor Surgery Light Model 2112FSS · Traditional | Adel Medical , Ltd. | 01/24/1986SE |