Cleared Traditional

K103056 - VISULAS TRION LASER SYSTEM WITH THE VITE OPTION

K103056 is an FDA 510(k) clearance for VISULAS TRION LASER SYSTEM WITH THE VIT..., manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K103056 · Carl Zeiss Meditec, AG · Ophthalmic device
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Feb 2011
Decision
109d
Days
Class 2
Risk

K103056 is an FDA 510(k) clearance for the VISULAS TRION LASER SYSTEM WITH THE VITE OPTION. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on February 1, 2011 after a review of 109 days - within the typical 510(k) review window.

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 Carl Zeiss Meditec, AG devices

FDA 510(k) Submission Details - K103056

510(k) Number K103056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2010
Decision Date February 01, 2011
Days to Decision 109 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
1d faster than avg
Panel avg: 110d · This submission: 109d
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 130
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