Sureflex Lithotripsy Laser Fibers
FDA 510(k) K140679 · American Medical Systems
510(k) numberK140679
Submission
- Device name
- Sureflex Lithotripsy Laser Fibers
- Applicant
- American Medical Systems
San Jose, CA, US - Received
- March 18, 2014
- Decision date
- June 20, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Sureflex Lithotripsy Laser Fibers cleared by the FDA?
Sureflex Lithotripsy Laser Fibers (K140679) received a 510(k) decision of Substantially Equivalent on June 20, 2014, 94 days after the submission was received.
What is the product code of K140679?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.