Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR
FDA 510(k) K013201 · Cardiofocus, Inc.
510(k) numberK013201
Submission
- Device name
- Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR
- Applicant
- Cardiofocus, Inc.
South West Ranches, FL, US - Received
- September 25, 2001
- Decision date
- March 18, 2002
- 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 Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR cleared by the FDA?
Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR (K013201) received a 510(k) decision of Substantially Equivalent on March 18, 2002, 174 days after the submission was received.
What is the product code of K013201?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.