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510(k) K000805

KAVO K.E.Y. LASER 1242 by Kavo America — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2000
Date Received
March 13, 2000
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.

Other clearances by Kavo America

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  • K030146 — KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ (August 3, 2005)
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  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

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