CERMAX300 Lightsource
FDA 510(k) K981469 · Cuda Products Co.
510(k) numberK981469
Submission
- Device name
- CERMAX300 Lightsource
- Applicant
- Cuda Products Co.
Jacksonville, FL, US - Received
- April 23, 1998
- Decision date
- July 9, 1998
- 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
Other 510(k)s with product code FSS
| 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 |
| 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 |
|---|---|---|
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | 12/16/1998SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | 08/18/1998SE |
| K980350 | Video Camera/Lightsource Combination Unit Model VCL-150GCJ · Traditional | 04/28/1998SE |
| K980166 | Lightsource or IlluminatorHET · Traditional | 04/01/1998SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | 04/30/1996SE |
| K951019 | Intraoral Video Scope and Window TubeEIA · Traditional | 05/10/1995SE |
| K943731 | Video OtoscopeERA · Traditional | 10/11/1994SE |
| K935818 | EndoscopeGDB · Traditional | 07/13/1994SE |
| K933369 | Cuda Products Corp. LightsourcesFCW · Traditional | 01/03/1994SE |
| K934337 | Cuda Products Corp. Model MX2-300 LightsourceFSW · Traditional | 11/18/1993SE |
Questions and answers
When was CERMAX300 Lightsource cleared by the FDA?
CERMAX300 Lightsource (K981469) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 77 days after the submission was received.
What is the product code of K981469?
The FDA product code is FSS – Light, Surgical, Floor Standing, a Class II (moderate risk) device regulated under 21 CFR 878.4580.