MODEL LS 840, CO2 LASER— 510(k) K864563

Substantially Equivalent for Some Indications

Cooper Lasersonics, Inc.

FDA 510(k) clearance K864563 for MODEL LS 840, CO2 LASER, Substantially Equivalent for Some Indications on 1987-04-09. Applicant: Cooper Lasersonics, Inc..

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1986-11-19
Decision date: 1987-04-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Santa Clara, 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.