Cleared Traditional

K091581 - SUPRA 577.Y LASER

K091581 is an FDA 510(k) clearance for SUPRA 577.Y LASER, manufactured by Quantel Medical. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K091581 · Quantel Medical · Ophthalmic device
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Jun 2009
Decision
14d
Days
Class 2
Risk

K091581 is an FDA 510(k) clearance for the SUPRA 577.Y LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Quantel Medical (Clermont-Ferrand Cedex 2, FR). The FDA issued a Cleared decision on June 16, 2009 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantel Medical devices

FDA 510(k) Submission Details - K091581

510(k) Number K091581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date June 16, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQF Laser, Ophthalmic

All 137
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K091581.
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
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K081946 · Quantel Medical · Mar 2009
NEXT GENERATION LASER
K062624 · Alcon Laboratories · Nov 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776 · Quantel Medical · Apr 2007