Cleared Traditional

K000457 - VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES

Also marketed or referenced as:
PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

K000457 is an FDA 510(k) clearance for VERTEFUSION-PHOTODYNAMIC THERAPY PAK, manufactured by Retinalabs.Com. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K000457 · Retinalabs.Com · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
88d
Days
Class 1
Risk

K000457 is an FDA 510(k) clearance for the VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Retinalabs.Com (Atlanta, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Retinalabs.Com devices

FDA 510(k) Submission Details - K000457

510(k) Number K000457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date May 09, 2000
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 49
Devices cleared under the same product code (HMX) and FDA review panel - the closest regulatory comparables to K000457.
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
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ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION
K921488 · Surgical Technologies, Inc. · May 1992
VITREORETINAL INFUSION CANNULA
K904074 · Visitec Co. · Feb 1991
STORZ INFUSION CANNULA
K882884 · Storz Instrument Co. · Aug 1988
PRISMA DISPOSABLE GILLS ANGLED I/A CANNULA
K874968 · Advanced Surgical Products, Inc. · Apr 1988