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510(k) K092621

PASCAL STREAMLINE PHOTOCOAGULATOR by Topcon Medical Laser Systems, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2009
Date Received
August 26, 2009
Clearance Type
Special
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.

  • K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (May 25, 2018)
  • K171488 — PSLT for PASCAL Streamline (November 27, 2017)
  • K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (May 15, 2013)
  • K111108 — PASCAL STREAMLINE 577 (WITH ACCESSORIES) (August 11, 2011)
  • K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (March 3, 2005)

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