Cleared Traditional

K002031 - PHACOFRAGMENTATION SYSTEM MEGATRON

K002031 is an FDA 510(k) clearance for PHACOFRAGMENTATION SYSTEM MEGATRON, manufactured by Asclepion-Meditec AG. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K002031 · Asclepion-Meditec AG · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
177d
Days
Class 2
Risk

K002031 is an FDA 510(k) clearance for the PHACOFRAGMENTATION SYSTEM MEGATRON. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Asclepion-Meditec AG (Irvine, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 177 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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.

FDA 510(k) Submission Details - K002031

510(k) Number K002031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date December 27, 2000
Days to Decision 177 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
67d slower than avg
Panel avg: 110d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 313
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K002031.
MOJAVE CATARACT EXTRACTION SYSTEM
K003638 · Allergan, Inc. · Feb 2001
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K003512 · A.R.C. Laser AG · Feb 2001
PHACOGARD
K002932 · Syntec, Inc. · Jan 2001
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K002986 · A.R.C. Laser AG · Nov 2000
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K002812 · Michael Reynard, M.D. · Nov 2000
OCUSYSTEM ART ADVANTAGE, MODEL 995
K991852 · Surgical Design Corp. · Jul 1999
K002031 · PHACOFRAGMENTATION SYSTEM MEGATRON
Download PDF FDA Summary Asclepion-Meditec AG