Cleared Traditional

K002986 - A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5

K002986 is an FDA 510(k) clearance for A.R.C. LOW BUBBLE TURBO NEEDLE, 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 65-day FDA review.

K002986 · A.R.C. Laser AG · Ophthalmic device
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Nov 2000
Decision
65d
Days
Class 2
Risk

K002986 is an FDA 510(k) clearance for the A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5. 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 November 29, 2000 after a review of 65 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 - K002986

510(k) Number K002986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date November 29, 2000
Days to Decision 65 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
45d faster than avg
Panel avg: 110d · This submission: 65d
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
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