Cleared Traditional

K971186 - AMO DIPLOMAX/OPSYS CONSOLE

K971186 is an FDA 510(k) clearance for AMO DIPLOMAX/OPSYS CONSOLE, manufactured by Allergan, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971186 · Allergan, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
73d
Days
Class 2
Risk

K971186 is an FDA 510(k) clearance for the AMO DIPLOMAX/OPSYS CONSOLE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on June 13, 1997 after a review of 73 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 Allergan, Inc. devices

FDA 510(k) Submission Details - K971186

510(k) Number K971186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1997
Decision Date June 13, 1997
Days to Decision 73 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
37d faster than avg
Panel avg: 110d · This submission: 73d
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 194
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K971186.
AUTOMATED CHAMBER MAINTENANCE MODULE
K971795 · Paradigm Medical Industries, Inc. · Jul 1997
WELCH ALLYN PHACO ILLUMINATOR
K971750 · Welch Allyn, Inc. · Jun 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · Storz Instrument Co. · Jun 1997
BAYERS BIMANUAL I/A HANDPIECES
K971064 · Visioncare Devices, Inc. · Jun 1997
DGH MODEL 9000
K965127 · Dgh Technology, Inc. · Mar 1997
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
K964018 · Michael Reynard, M.D. · Feb 1997