Cleared Special

SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR (K081946) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081946 · Quantel Medical · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
260d
Days
Class 2
Risk

K081946 is an FDA 510(k) clearance for the SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 25, 2009 after a review of 260 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quantel Medical devices

Submission Details

510(k) Number K081946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2008
Decision Date March 25, 2009
Days to Decision 260 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
150d slower than avg
Panel avg: 110d · This submission: 260d
Pathway characteristics
Modification to existing cleared device.

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.

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