A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5— 510(k) K002986

Name: FDA 510(k) clearance K002986
Creator: U.S. Food and Drug Administration
Published: 2000-11-29

Substantially Equivalent

A.R.C. Laser AG

FDA 510(k) clearance K002986 for A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5, Substantially Equivalent on 2000-11-29. Applicant: A.R.C. Laser AG. Device class: 2.

Clearance details

Applicant: A.R.C. Laser AG
Product code: Product code HQC
Device class: Class 2
Regulation: 21 CFR 886.4670
Advisory panel: Ophthalmic
Date received: 2000-09-25
Decision date: 2000-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K003512 — LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II2001-02-08
K001511 — O-LAS OPHTHALMIC PHOTODISRUPTOR2000-07-19

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.