Cleared Traditional

K130933 - SOLUTIS

K130933 is the FDA 510(k) clearance for SOLUTIS by Quantel Medical. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K130933 · Quantel Medical · Ophthalmic device
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Aug 2013
Decision
120d
Days
Class 2
Risk

K130933 is an FDA 510(k) clearance for the SOLUTIS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Quantel Medical (North Reading, US). The FDA issued a Cleared decision on August 2, 2013 after a review of 120 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 Quantel Medical devices

Submission Details

510(k) Number K130933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2013
Decision Date August 02, 2013
Days to Decision 120 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
10d slower than avg
Panel avg: 110d · This submission: 120d
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 64
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