FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)— 510(k) K070284

Substantially Equivalent

Reliant Technologies, Inc.

FDA 510(k) clearance K070284 for FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM), Substantially Equivalent on 2007-05-17. Applicant: Reliant Technologies, Inc..

Clearance details

Applicant: Reliant Technologies, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2007-01-29
Decision date: 2007-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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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.