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510(k) K171488

PSLT for PASCAL Streamline by Topcon Medical Laser Systems, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2017
Date Received
May 22, 2017
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.

  • K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (May 25, 2018)
  • 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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