INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB— 510(k) K963969
Substantially EquivalentIndigo 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.. Device class: 2.
Clearance details
- Applicant
- Indigo Medical, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code GEX
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view all- K992262 — INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
- K990851 — INDIGO LASEROPTIC TREATMENT SYSTEM
- K963081 — INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS
- K955758 — INDIGO MEDICAL MODEL IDL 830E
- K954195 — INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
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, through . 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.