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510(k) K031954

COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS by New Star Lasers, Inc. — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2003
Date Received
June 25, 2003
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 New Star Lasers, Inc.

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  • K101783 — COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE (September 13, 2010)
  • K092964 — COOLTOUCH VARIA ND:YAG LASER SYSTEM (December 11, 2009)
  • K090410 — COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY (March 27, 2009)
  • K081628 — MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO (June 20, 2008)
  • K080163 — COOLTOUCH MODELS LC215 AND COOLLIPO (April 10, 2008)
  • K072751 — COOLTOUCH MODELS NS 160 AND LC215 COOLIPO (January 2, 2008)
  • K072424 — COOLTOUCH, MODEL LC215,COOLLIPO (October 3, 2007)

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