BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E— 510(k) K241358
Substantially EquivalentSun Pharmaceutical Industries, Inc.
FDA 510(k) clearance K241358 for BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E, Substantially Equivalent on 2024-06-13. Applicant: Sun Pharmaceutical Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Pharmaceutical Industries, 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
- Special
- Location
- Billerica, MA, US
Recent devices under product code GEX
view allAdverse 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.