EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000— 510(k) K992914

Name: FDA 510(k) clearance K992914
Creator: U.S. Food and Drug Administration
Published: 2000-01-27

Substantially Equivalent

Acculase, Inc.

FDA 510(k) clearance K992914 for EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000, Substantially Equivalent on 2000-01-27. Applicant: Acculase, Inc.. Device class: 2.

Clearance details

Applicant: Acculase, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1999-08-30
Decision date: 2000-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.