Endobeam Holmium Laser Fibers
FDA 510(k) K120926 · C.R. Bard, Inc.
510(k) numberK120926
Submission
- Device name
- Endobeam Holmium Laser Fibers
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- March 27, 2012
- Decision date
- July 27, 2012
- 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 Endobeam Holmium Laser Fibers cleared by the FDA?
Endobeam Holmium Laser Fibers (K120926) received a 510(k) decision of Substantially Equivalent on July 27, 2012, 122 days after the submission was received.
What is the product code of K120926?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.