Cleared Traditional

K100019 - PASCAL STREAMLINE PHOTOCOAGULATOR

K100019 is an FDA 510(k) clearance for PASCAL STREAMLINE PHOTOCOAGULATOR, manufactured by Optimedica Corporation. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K100019 · Optimedica Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
119d
Days
Class 2
Risk

K100019 is an FDA 510(k) clearance for the PASCAL STREAMLINE PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Optimedica Corporation (Sunnyvale, US). The FDA issued a Cleared decision on May 4, 2010 after a review of 119 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 Optimedica Corporation devices

FDA 510(k) Submission Details - K100019

510(k) Number K100019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2010
Decision Date May 04, 2010
Days to Decision 119 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
9d slower than avg
Panel avg: 110d · This submission: 119d
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 138
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K100019.
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
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K091581 · Quantel Medical · Jun 2009
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
K081946 · Quantel Medical · Mar 2009
NEXT GENERATION LASER
K062624 · Alcon Laboratories · Nov 2007