Clearance Summary
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E received FDA 510(k) clearance under submission number K241358, sponsored by Sun Pharmaceutical Industries, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-06-13.
- Submission: K241358
- Applicant / Sponsor: Sun Pharmaceutical Industries, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-06-13
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.