Cleared Traditional

K834543 - OCUCARE ULTRASOUND TIP & FREEDOM PACK

K834543 is the FDA 510(k) clearance for OCUCARE ULTRASOUND TIP & FREEDOM PACK by Intermedics Intraocular, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K834543 · Intermedics Intraocular, Inc. · Ophthalmic device
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Mar 1984
Decision
99d
Days
Class 2
Risk

K834543 is an FDA 510(k) clearance for the OCUCARE ULTRASOUND TIP & FREEDOM PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Intermedics Intraocular, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 99 days - within the typical 510(k) review window.

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 Intermedics Intraocular, Inc. devices

Submission Details

510(k) Number K834543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date March 16, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K834543.
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · Chiron Vision Corp. · Aug 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · Chiron Vision Corp. · May 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · Chiron Vision Corp. · Apr 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · CooperVision, Inc. · Mar 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · CooperVision, Inc. · Mar 1984
DISPOSABLE I/A HANDPIECE
K833784 · CooperVision, Inc. · Feb 1984