Cleared Traditional

K113857 - SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

K113857 is an FDA 510(k) clearance for SYNERGETICS DIRECTIONAL ENDOOCULAR LASE..., manufactured by Synergetics, Inc.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

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

FDA 510(k) Submission Details - K113857

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
Combination Product No
PCCP Authorized No
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.

HQB Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K113857.
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