Cleared Special

K092621 - PASCAL STREAMLINE PHOTOCOAGULATOR

K092621 is an FDA 510(k) clearance for PASCAL STREAMLINE PHOTOCOAGULATOR, manufactured by Topcon Medical Laser Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Special 510(k) pathway after a 30-day FDA review.

K092621 · Topcon Medical Laser Systems, Inc. · Ophthalmic device
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Sep 2009
Decision
30d
Days
Class 2
Risk

K092621 is an FDA 510(k) clearance for the PASCAL STREAMLINE PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Topcon Medical Laser Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 25, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Topcon Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K092621

510(k) Number K092621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2009
Decision Date September 25, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 110d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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. 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 125
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K092621.
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
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NEXT GENERATION LASER
K062624 · Alcon Laboratories · Nov 2007