Cleared Traditional

K170067 - Easyret (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170067 · Quantel Medical · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
197d
Days
Class 2
Risk

K170067 is an FDA 510(k) clearance for the Easyret. 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 July 25, 2017 after a review of 197 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantel Medical devices

Submission Details

510(k) Number K170067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date July 25, 2017
Days to Decision 197 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 110d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - HQF Laser, Ophthalmic

All 179
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K170067.
Voyager DSLT (430840610)
K252979 · Belkin Vision, Ltd. · Apr 2026
INTEGRE LIO
K251507 · Quantel Medical · Feb 2026
Navilas Laser System 577sl (156691)
K251772 · Od-Os GmbH · Oct 2025
EyeQ nanoECP
K243014 · Eyeq, Inc. · Jun 2025
Leos Laser and Endoscopy System
K240615 · Beaver-Visitec International, Inc. · Apr 2025
LYNX Photocoagulator
K242397 · Norlase Aps · Oct 2024