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510(k) K052777

LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D by Ellex Medical Pty, Ltd. — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2006
Date Received
October 3, 2005
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.

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  • K003955 — LASEREX INTEGRE, MODEL LP2532 (March 15, 2001)

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