INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB— 510(k) K963969

Substantially Equivalent

Indigo Medical, Inc.

FDA 510(k) clearance K963969 for INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB, Substantially Equivalent on 1997-12-23. Applicant: Indigo Medical, Inc..

Clearance details

Applicant: Indigo Medical, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1996-10-03
Decision date: 1997-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.