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510(k) K151473

NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module by Focus Medical, LLC — Product Code GEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2015
Date Received
June 1, 2015
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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  • K101152 — NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAM (August 18, 2010)
  • K041829 — FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS (September 7, 2004)
  • K032667 — FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) (January 23, 2004)
  • K031828 — NATURALASE LP ND:YAG LASER (July 17, 2003)
  • K992597 — LORAD LT-100 LASER TREATMENT SYSTEM (April 24, 2000)
  • K970970 — CARDIOMATCH (June 13, 1997)

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