K241358
- 510(k) number
- K241358
- Device name
- BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
- Applicant
- Sun Pharmaceutical Industries, Inc. MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-13
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241358
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.