MOORVMS-LDF1 and MOORVMS-LDF2 Laser Doppler Perfusion and Temperature Monitors
FDA 510(k) K083082 · Moor Instruments, Ltd.
Submission
- Device name
- MOORVMS-LDF1 and MOORVMS-LDF2 Laser Doppler Perfusion and Temperature Monitors
- Applicant
- Moor Instruments, Ltd.
Axminster, Devon, GB - Received
- October 16, 2008
- Decision date
- January 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser…DPT · Traditional | 05/12/2016SE |
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | 01/29/2014SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | 01/03/2013SE |
| K112826 | Noorvms-Oxy Tissue Oxygen and Temperture MonitorMUD · Traditional | 10/10/2012SE |
| K102433 | Moorvms-Pres Pressure Cuff ControllerDPW · Traditional | 11/18/2010SE |
| K060976 | MOORLD12-B1 Laser Doppler Burns ImagerDPT · Traditional | 03/27/2007SE |
| K063586 | Moorflpi Full-Field Laser Perfusion ImagerDPT · Traditional | 01/25/2007SE |
| K063561 | Moorldls Laser Doppler Line ScannerDPT · Traditional | 01/19/2007SE |
| K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRDPT · Traditional | 12/10/2003SE |
| K011070 | DRT4 Laser Doppler Perfusion and Temperature MonitorGEX · Traditional | 11/07/2001SE |
Questions and answers
When was MOORVMS-LDF1 and MOORVMS-LDF2 Laser Doppler Perfusion and Temperature Monitors cleared by the FDA?
MOORVMS-LDF1 and MOORVMS-LDF2 Laser Doppler Perfusion and Temperature Monitors (K083082) received a 510(k) decision of Substantially Equivalent on January 13, 2009, 89 days after the submission was received.
What is the product code of K083082?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.