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510(k) K180402

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar by Topcon Medical Laser Systems, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2018
Date Received
February 14, 2018
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.

  • 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)
  • K092621 — PASCAL STREAMLINE PHOTOCOAGULATOR (September 25, 2009)
  • K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 (March 3, 2005)

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