The following data is part of a premarket notification filed by Lumitex, Inc. with the FDA for Bilisoft Phototherapy System.
| Device ID | K053568 |
| 510k Number | K053568 |
| Device Name: | BILISOFT PHOTOTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | LUMITEX, INC. 8443 DOW CIR. Strongsville, OH 44136 |
| Contact | Jeff Williams |
| Correspondent | Jeff Williams LUMITEX, INC. 8443 DOW CIR. Strongsville, OH 44136 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812432020484 | K053568 | 000 |
| 00812432020477 | K053568 | 000 |
| 00812432020460 | K053568 | 000 |
| 00812432020453 | K053568 | 000 |
| 00840682116565 | K053568 | 000 |
| 00840682116558 | K053568 | 000 |
| 00840682116534 | K053568 | 000 |