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510(k) K111108

PASCAL STREAMLINE 577 (WITH ACCESSORIES) by Topcon Medical Laser Systems, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2011
Date Received
April 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

Other clearances by Topcon Medical Laser Systems, Inc.

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  • K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (May 15, 2013)
  • K092621 — PASCAL STREAMLINE PHOTOCOAGULATOR (September 25, 2009)
  • K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (March 3, 2005)

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