APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM— 510(k) K113018

Substantially Equivalent

BEIJING SYNTECH LASER CO., LTD.

FDA 510(k) clearance K113018 for APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM, Substantially Equivalent on 2012-12-14. Applicant: BEIJING SYNTECH LASER CO., LTD..

Clearance details

Applicant: BEIJING SYNTECH LASER CO., LTD.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2011-10-11
Decision date: 2012-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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.