SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK— 510(k) K050648

Name: FDA 510(k) clearance K050648
Creator: U.S. Food and Drug Administration
Published: 2005-04-05

Substantially Equivalent

Advanced Medical Optics, Inc.

FDA 510(k) clearance K050648 for SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK, Substantially Equivalent on 2005-04-05. Applicant: Advanced Medical Optics, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Medical Optics, Inc.
Product code: Product code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 2005-03-14
Decision date: 2005-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQC

view all

K262097 — MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)2026-10-15
K261264 — Stellaris Elite vision enhancement system +7 more2026-05-15
K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)2026-03-25
K250501 — System Sophi2025-11-14
K243395 — MICOR 700 with Auto I/A2025-08-08

More clearances from Advanced Medical Optics, Inc.

view all

K081681 — VITRECTOMY CUTTER AND ACCESSORIES2008-10-08
K081545 — ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR302008-10-02
K060366 — THE AMO OPHTHALMIC SURGICAL SYSTEM2006-04-07
K042562 — LENS PLUS REWETTING DROPS2005-07-29
K040839 — COMPLETE BLINK-N-CLEAN LENS DROPS2004-10-19

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 →

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