Cleared Traditional

K111108 - PASCAL STREAMLINE 577 (WITH ACCESSORIES)

K111108 is the FDA 510(k) clearance for PASCAL STREAMLINE 577 (WITH ACCESSORIES) 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 113-day FDA review.

K111108 · Topcon Medical Laser Systems, Inc. · Ophthalmic device
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Aug 2011
Decision
113d
Days
Class 2
Risk

K111108 is an FDA 510(k) clearance for the PASCAL STREAMLINE 577 (WITH ACCESSORIES). 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 August 11, 2011 after a review of 113 days - within the typical 510(k) review window.

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 K111108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2011
Decision Date August 11, 2011
Days to Decision 113 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
3d slower than avg
Panel avg: 110d · This submission: 113d
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 K111108.
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