510(k) K241358 · GEX Powered Laser Surgical Instrument
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
| Applicant | Sun Pharmaceutical Industries, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Jun 13, 2024 |
| Received | May 14, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241358
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.