CANDELA MODEL SPT-1, PULSED DYE LASER— 510(k) K861179

Substantially Equivalent

Candela Corp.

FDA 510(k) clearance K861179 for CANDELA MODEL SPT-1, PULSED DYE LASER, Substantially Equivalent on 1986-11-20. Applicant: Candela Corp..

Clearance details

Applicant: Candela Corp.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1986-03-31
Decision date: 1986-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, 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.