Cleared Traditional

K111108 - PASCAL STREAMLINE 577 (WITH ACCESSORIES)

K111108 is an FDA 510(k) clearance for PASCAL STREAMLINE 577 (WITH ACCESSORIES), 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 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

FDA 510(k) Submission Details - K111108

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
Combination Product No
PCCP Authorized No
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.

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 124
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