Angiodynamics, Inc. Venacure 1470 Laser
FDA 510(k) K110225 · AngioDynamics, Inc.
510(k) numberK110225
Submission
- Device name
- Angiodynamics, Inc. Venacure 1470 Laser
- Applicant
- AngioDynamics, Inc.
Latham, NY, US - Received
- January 25, 2011
- Decision date
- May 13, 2011
- 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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Questions and answers
When was Angiodynamics, Inc. Venacure 1470 Laser cleared by the FDA?
Angiodynamics, Inc. Venacure 1470 Laser (K110225) received a 510(k) decision of Substantially Equivalent on May 13, 2011, 108 days after the submission was received.
What is the product code of K110225?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.