Cleared Traditional

K201502 - Vitra 810

K201502 is an FDA 510(k) clearance for Vitra 810, 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 62-day FDA review.

K201502 · Quantel Medical · Ophthalmic device
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Aug 2020
Decision
62d
Days
Class 2
Risk

K201502 is an FDA 510(k) clearance for the Vitra 810. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Quantel Medical (Cournon D' Auvergne-Cedex, FR). The FDA issued a Cleared decision on August 6, 2020 after a review of 62 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 - K201502

510(k) Number K201502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2020
Decision Date August 06, 2020
Days to Decision 62 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
48d faster than avg
Panel avg: 110d · This submission: 62d
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 Consultant

O'Connell Regulatory Consultants, Inc.
Maureen O'Connell

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 84
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K201502.
Ophthalmic Yag Laser System YC-200
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Iridex 810 Laser
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LION Photocoagulator
K201623 · Norlase Aps · Aug 2020
Ophthalmic Yag Laser System YC-200
K192045 · Nidek Co., Ltd. · Nov 2019
LightLas Pattern Scanning System - TruScan Pro
K190448 · Light-Med(Usa), Inc. · May 2019
Leaf Photocoagulator
K190083 · Norlase Aps · May 2019