Cook Odyssey Holmium Laser System, Model 30W
FDA 510(k) K080525 · Cook Urological, Inc.
510(k) numberK080525
Submission
- Device name
- Cook Odyssey Holmium Laser System, Model 30W
- Applicant
- Cook Urological, Inc.
Bloomington, IN, US - Received
- February 26, 2008
- Decision date
- April 17, 2008
- 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 Cook Odyssey Holmium Laser System, Model 30W cleared by the FDA?
Cook Odyssey Holmium Laser System, Model 30W (K080525) received a 510(k) decision of Substantially Equivalent on April 17, 2008, 51 days after the submission was received.
What is the product code of K080525?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.