Cleared Traditional

GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (K954306) - FDA 510(k) Clearance

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

K954306 · Gamp & Assoc. · Ophthalmic device
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Dec 1995
Decision
98d
Days
Class 2
Risk

K954306 is an FDA 510(k) clearance for the GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Gamp & Assoc. (Chesterfield, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 98 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 Gamp & Assoc. devices

Submission Details

510(k) Number K954306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date December 22, 1995
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
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 K954306.
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263 · Vortex Surgical, Inc. · Nov 2022
MAXReach Laser Probe
K191846 · Vortex Surgical, Inc. · Dec 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · Vitreq BV · May 2019