Cleared Traditional

K854375 - COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR

K854375 is an FDA 510(k) clearance for COOPERVISION ACAP POWER DRIVE ULTRASONI..., manufactured by CooperVision, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K854375 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
58d
Days
Class 2
Risk

K854375 is an FDA 510(k) clearance for the COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by CooperVision, Inc. (Irvine, US). The FDA issued a Cleared decision on December 27, 1985 after a review of 58 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 - K854375

510(k) Number K854375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1985
Decision Date December 27, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 110d · This submission: 58d
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 315
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K854375.
AM-100 I/A AMPAC
K860770 · Dravon Medical, Inc. · Apr 1986
PHACO PACKS, 1A PACKS & PACK COMPONENTS
K854116 · Medical Corp. of America · Dec 1985
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
K854225 · Advanced Medical Technology, Inc. · Dec 1985
O.M.S. ULTRA-PHACO
K844373 · Optical Micro Systems, Inc. · Dec 1985
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
K853883 · Medical Corp. of America · Oct 1985
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
K853189 · Aesthetech Corp. · Sep 1985
K854375 · COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
Download PDF CooperVision, Inc.