Flexiva SF Side-Firing Single-Use Laser Fiber
FDA 510(k) K140503 · Boston Scientific
510(k) numberK140503
Submission
- Device name
- Flexiva SF Side-Firing Single-Use Laser Fiber
- Applicant
- Boston Scientific
Marlboro, MA, US - Received
- February 27, 2014
- Decision date
- April 15, 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 Flexiva SF Side-Firing Single-Use Laser Fiber cleared by the FDA?
Flexiva SF Side-Firing Single-Use Laser Fiber (K140503) received a 510(k) decision of Substantially Equivalent on April 15, 2014, 47 days after the submission was received.
What is the product code of K140503?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.