Cleared Traditional

K123542 - PASCAL SYNTHESIS (532NM/577NM) OPTHALMI...

K123542 is the FDA 510(k) clearance for PASCAL SYNTHESIS (532NM/577NM) OPTHALMI... by Topcon Medical Laser Systems, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K123542 · Topcon Medical Laser Systems, Inc. · Ophthalmic device
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May 2013
Decision
177d
Days
Class 2
Risk

K123542 is an FDA 510(k) clearance for the PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Topcon Medical Laser Systems, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on May 15, 2013 after a review of 177 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

Submission Details

510(k) Number K123542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date May 15, 2013
Days to Decision 177 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 110d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 46
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K123542.
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
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · Bausch & Lomb, Inc. · Feb 2004
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · Nidek, Inc. · Feb 2002
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · Nidek, Inc. · Sep 1995