Cleared Traditional

K953539 - DM001 DISPOSABLE PACK

K953539 is an FDA 510(k) clearance for DM001 DISPOSABLE PACK, manufactured by American Optisurgical, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K953539 · American Optisurgical, Inc. · Ophthalmic device
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Dec 1995
Decision
151d
Days
Class 2
Risk

K953539 is an FDA 510(k) clearance for the DM001 DISPOSABLE PACK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by American Optisurgical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 151 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 American Optisurgical, Inc. devices

FDA 510(k) Submission Details - K953539

510(k) Number K953539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1995
Decision Date December 26, 1995
Days to Decision 151 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 110d · This submission: 151d
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 163
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K953539.
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