Cleared Traditional

K003512 - LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II

K003512 is an FDA 510(k) clearance for LASER PACK I, manufactured by A.R.C. Laser AG. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K003512 · A.R.C. Laser AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
86d
Days
Class 2
Risk

K003512 is an FDA 510(k) clearance for the LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by A.R.C. Laser AG (Salt Lake City, US). The FDA issued a Cleared decision on February 8, 2001 after a review of 86 days - a notably fast clearance 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: 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 A.R.C. Laser AG devices

FDA 510(k) Submission Details - K003512

510(k) Number K003512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2000
Decision Date February 08, 2001
Days to Decision 86 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
24d faster than avg
Panel avg: 110d · This submission: 86d
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 192
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K003512.
INFINITI
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OCUSYSTEM ART ADVANTAGE, MODEL 995
K991852 · Surgical Design Corp. · Jul 1999
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K984143 · Fibra Sonics, Inc. · Feb 1999
THE WAVE DIGITAL PHACO SYSTEM
K981989 · Circuit Tree · Aug 1998