Cleared Special

K081946 - SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR

K081946 is an FDA 510(k) clearance for SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR, manufactured by Quantel Medical. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Special 510(k) pathway after a 260-day FDA review.

K081946 · Quantel Medical · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K081946

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 110d · This submission: 260d
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 179
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K081946.
LIGHTLAS MODEL 532
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SOLX 790 TITANIUM SAPPHIRE LASER
K081774 · Solx, Inc. · Sep 2008
INTEGRE PRO, MODEL L2RY
K081565 · Ellex Medical Pty, Ltd. · Jul 2008
INTEGRE, MODEL LP581
K080423 · Ellex Medical Pty, Ltd. · Mar 2008
K081946 · SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
Download PDF FDA Summary Quantel Medical