Cleared Traditional

K921607 - IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE

K921607 is an FDA 510(k) clearance for IOLAB REUSABLE PERISTATIC CASSETTE/OPHT..., manufactured by Chiron Vision Corp.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K921607 · Chiron Vision Corp. · Ophthalmic device
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Jun 1992
Decision
88d
Days
Class 2
Risk

K921607 is an FDA 510(k) clearance for the IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Chiron Vision Corp. (Horsham, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 88 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 Chiron Vision Corp. devices

FDA 510(k) Submission Details - K921607

510(k) Number K921607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date June 30, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
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 K921607.
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