Cleared Traditional

K043236 - FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA

K043236 is an FDA 510(k) clearance for FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, 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 77-day FDA review.

K043236 · Quantel Medical · Ophthalmic device
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Feb 2005
Decision
77d
Days
Class 2
Risk

K043236 is an FDA 510(k) clearance for the FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Quantel Medical (Hot Springs, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 77 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 - K043236

510(k) Number K043236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date February 07, 2005
Days to Decision 77 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
33d faster than avg
Panel avg: 110d · This submission: 77d
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 137
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