AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM— 510(k) K951462

Name: FDA 510(k) clearance K951462
Creator: U.S. Food and Drug Administration
Published: 1995-06-15

Substantially Equivalent

Allergan Medical Optics

FDA 510(k) clearance K951462 for AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM, Substantially Equivalent on 1995-06-15. Applicant: Allergan Medical Optics. Device class: 2.

Clearance details

Applicant: Allergan Medical Optics
Product code: Code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 1995-03-30
Decision date: 1995-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQC

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K925254 — AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-381993-01-07
K924235 — AMO ELITE1992-12-23
K911998 — MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM1991-07-26

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K951462

K-number listed on FDA's recall record

Z-1033-2022 — TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,Class II·Ongoing·Johnson & Johnson Surgical Vision Inc·20220406

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951462.

Data sourced from openFDA. This site is unofficial and independent of the FDA.