Cleared Traditional

K171488 - PSLT for PASCAL Streamline

K171488 is an FDA 510(k) clearance for PSLT for PASCAL Streamline, manufactured by Topcon Medical Laser Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K171488 · Topcon Medical Laser Systems, Inc. · Ophthalmic device
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Nov 2017
Decision
189d
Days
Class 2
Risk

K171488 is an FDA 510(k) clearance for the PSLT for PASCAL Streamline. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Topcon Medical Laser Systems, Inc. (Livermore, US). The FDA issued a Cleared decision on November 27, 2017 after a review of 189 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Topcon Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K171488

510(k) Number K171488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date November 27, 2017
Days to Decision 189 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 110d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02231515 Terminated Interventional

Prospective,Randomized,Controlled Study to Assess Efficacy,Safety, and Tolerability of SLT vs. PLT in Patients With POAG

A Prospective, Randomized, Controlled Study to Assess Efficacy,Safety, and Tolerability of Selective Laser Trabeculoplasty vs. Pattern Laser Trabeculoplasty in Patients With Open-angle Glaucoma

29
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Glaucoma and Ocular Hypertension
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Kaweh Mansouri
Sponsor University Hospital, Geneva
Started 2014-04-01 → Primary completion 2016-04-01 → Completed 2016-06-01
Primary outcome
• Change in IOP from baseline to 1 month post-surgery as measured by tonometry
Secondary outcome
o Complete success: Reduction of at least 20% in IOP without medication
View full study on ClinicalTrials.gov

Regulatory Peers - HQF Laser, Ophthalmic

All 124
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K171488.
Leaf Photocoagulator
K190083 · Norlase Aps · May 2019
VISULAS green
K181682 · Carl Zeiss Meditec, AG · Mar 2019
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K180402 · Topcon Medical Laser Systems, Inc. · May 2018
Easyret
K170067 · Quantel Medical · Jul 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
K170302 · Nidek Co., Ltd. · Jun 2017
R:GEN Laser System
K153769 · Lutronic Corporation · Oct 2016