LASEAWAY Q-SWITCHED RUBY LASER SYSTEM— 510(k) K942343

Name: FDA 510(k) clearance K942343
Creator: U.S. Food and Drug Administration
Published: 1994-07-08

Substantially Equivalent

Polytec Pi, Inc.

FDA 510(k) clearance K942343 for LASEAWAY Q-SWITCHED RUBY LASER SYSTEM, Substantially Equivalent on 1994-07-08. Applicant: Polytec Pi, Inc.. Device class: 2.

Clearance details

Applicant: Polytec Pi, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 1994-05-16
Decision date: 1994-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, MA, 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.