Cleared Traditional

K020734 - SURGE-FREE ASPIRATION ADAPTER

K020734 is an FDA 510(k) clearance for SURGE-FREE ASPIRATION ADAPTER, manufactured by Staar Surgical Co.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K020734 · Staar Surgical Co. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
71d
Days
Class 2
Risk

K020734 is an FDA 510(k) clearance for the SURGE-FREE ASPIRATION ADAPTER. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on May 16, 2002 after a review of 71 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.

FDA 510(k) Submission Details - K020734

510(k) Number K020734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date May 16, 2002
Days to Decision 71 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
39d faster than avg
Panel avg: 110d · This submission: 71d
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 316
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K020734.
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · Benjamin Biomedical, Inc. · Sep 2002
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K020527 · American Optisurgical, Inc. · Jul 2002
INFINITI
K021566 · Alcon Laboratories, Inc. · Jul 2002
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
K020734 · SURGE-FREE ASPIRATION ADAPTER
Download PDF FDA Summary Staar Surgical Co.