Cleared Traditional

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (K113857) - FDA 510(k) Clearance

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

K113857 · Synergetics, Inc. · Ophthalmic device
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Apr 2012
Decision
115d
Days
Class 2
Risk

K113857 is an FDA 510(k) clearance for the SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Synergetics, Inc. (O' Fallon, US). The FDA issued a Cleared decision on April 23, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 Synergetics, Inc. devices

Submission Details

510(k) Number K113857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2011
Decision Date April 23, 2012
Days to Decision 115 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
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 29
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K113857.
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K182646 · Vitreq BV · May 2019