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510(k) K083927

WATERLASE MD by Biolase Technology, Inc. — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2009
Date Received
December 31, 2008
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 Biolase Technology, Inc.

  • K122368 — WATERLASE IPLUS ALL TISSUE LASER (May 2, 2013)
  • K130465 — EPIC 10S (April 11, 2013)
  • K121327 — DIOLASE 10S (February 1, 2013)
  • K121286 — EPIC 10 (September 28, 2012)
  • K101658 — WATERLASE MD TURBO PLUS MODEL 7200XXX (August 11, 2010)
  • K093852 — EZLASE 3 LASER SYSTEM (March 12, 2010)
  • K091746 — WATERLASE MD, MODEL 7100102 (December 7, 2009)
  • K091922 — WATERLASE C100, MODEL 7100104 (July 14, 2009)
  • K083595 — EZLASE (April 14, 2009)
  • K090181 — WATERLASE MD (February 11, 2009)

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