CO2 FRACTIONAL LASER— 510(k) K131837

Name: FDA 510(k) clearance K131837
Creator: U.S. Food and Drug Administration
Published: 2014-01-22

Substantially Equivalent

Beijing Honkon Technologies Co., Ltd.

FDA 510(k) clearance K131837 for CO2 FRACTIONAL LASER, Substantially Equivalent on 2014-01-22. Applicant: Beijing Honkon Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Honkon Technologies Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2013-06-20
Decision date: 2014-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

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.