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510(k) K210925

Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber by Boston Scientific — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2021
Date Received
March 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Powered Laser Surgical Instrument
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

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, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

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