510(k) K171488

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

K171488 is an FDA 510(k) premarket notification submitted by Topcon Medical Laser Systems, Inc. for the device "PSLT for PASCAL Streamline". The FDA issued a decision of Substantially Equivalent on November 27, 2017. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Topcon Medical Laser Systems, Inc. has at least 5 other 510(k) clearances on record.

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