510(k) K963193

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 13, 1996

Date Received

August 15, 1996

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

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.