Cleared Traditional

K960811 - PHACOSCOPE

K960811 is an FDA 510(k) clearance for PHACOSCOPE, manufactured by Saint John'S Plaza Medical Group. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K960811 · Saint John'S Plaza Medical Group · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
218d
Days
Class 2
Risk

K960811 is an FDA 510(k) clearance for the PHACOSCOPE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Saint John'S Plaza Medical Group (Santa Monica, US). The FDA issued a Cleared decision on October 2, 1996 after a review of 218 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Saint John'S Plaza Medical Group devices

FDA 510(k) Submission Details - K960811

510(k) Number K960811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date October 02, 1996
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
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 186
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K960811.
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K962402 · Allergan, Inc. · Sep 1996
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K960003 · Storz Instrument Co. · Aug 1996